I came in this morning and noticed a huge spike on our -30 freezer temp chart from the evening prior.  The Freezer was at -12 for about 2 hours.  We have FFP and Cryo in there.  Does this mean I have to discard my entire inventory? Im having a hard time finding an answer via the technical manual

 

Any advice/input is appreciated!

I would discard the entire inventory. Then I would wonder if there was an alarm activation. If not, why not? If alarm was activated, was action taken or was it ignored? Do you have a backup freezer?

Oh I can tell you why, a tech got tired of hearing the alarm and switched the key to off.  Apparently there is a glitch in our freezer so when you do that the entire unit shut down.

Thanks for your help

If you don't discard and transfuse any of those products - I wouldn't want to explain to the FDA or any regulatory agency why I did not get rid of components not stored according to regulations. 

 

Do you still employ that tech?

I wouldn't discard out of hand. We had a similar situation where we were temporarily storing frozen products in a freezer that did not have continuous monitoring and a tech reported a temp of -17C. Our supervisor submitted a biologic deviation report to CBER/FDA and we were able to use the products, which were obviously still frozen.

 

I would quarantine everything and check into this with the FDA -- while your products were a bit warmer than ours I would say that -12C should still be pretty frozen.  I believe that we quarantined until the report was reviewed and the products were released. Seems a shame to toss everything without looking into it.

Thanks all for your input.

According to my blood supplier, I should be ok with a visual inspection of the units so long as they didnt look like they thawed.  Nothing was said of a FDA Biologically deviation report so I will def be looking into that. 

Here's a quick link to the FDA page regarding it with the guidelines. It includes this verbage in section B.

 

"What Do I Report? (21 CFR 606.171()

1. Under 21 CFR 606.171(, you must report any event and any information relevant to the event associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution, of both licensed and unlicensed blood or blood components, including Source Plasma, if that event meets all the following criteria:
2. Either
   1. Represents a deviation from current good manufacturing practice, applicable regulations, applicable standards, or established specifications that may affect the safety, purity, or potency of that product; or
   2. Represents an unexpected or unforeseeable event that may affect the safety, purity, or potency of that product; and
3. Occurs in your facility or a facility under contract with you; and
4. Involves a distributed blood or blood component.

An adequate procedure for deviation reporting (21 CFR 606 . 100() would include steps for determining whether or not an event is one for which a report must be submitted. The decision to report should be based on whether the event had the potential to affect the safety, purity, or potency of a product. The terms safety, purity, and potency are defined in 21 CFR 600.3(p), ®, and (s), respectively."

 

Better safe than sorry! The most time consuming part for us was logging all the unit numbers from the freezer.

Sadly, I think you will have to discard all of the products. They were well outside the minimum temperature for quite a while. And there needs to be corrective action for the tech involved as well as preventative action so this never happens again. Hide the key maybe?

You would only need to file a BPD with the FDA if you distribute any of these products for transfusion or transfer.  Just because you had that event is not cause to report.

All may not be lost. One of our seminar speakers last week did a talk on FFP which included some data on stability of FFP stored for various times/temps out of range. I'll see if I can get the references from her.

Thanks for all the input.  As of now our inventory is Quarantined with a small stock of new frozen product for emergencies.  

I had sent a few suspicious looking products back to the supplier to look at, and they aggreed and put them through their review process.  So we are waiting to speak with them

I cant imagine that being at -10 for 2 hours would thaw the product that much, but I want to be sure.

Thankfully no one was transfused with any frozen product within that time period or after.

Ahhh!  We just had this happen.  The freezer completely died and the alarm failed to go off.  By the time it was discovered, the products were all at -8 and had been out of temp for hours.  We discarded all of the products.  Turns out that engineering knocked a wire loose when working on the motor and our wireless alarm failed to be noticed by security because someone had closed out the program....Needless to say, I was NOT a happy camper. 

 

This also happened about  8 years ago when someone had turned off the alarm. No one fessed up to it.... When dayshift came in all the products were thawed and freezer felt more like an incubator.  At the time, the freezer was located in another department.  We since have gotten a new lab where we actually have room for all of our equipment!

Ahhh!  We just had this happen.  The freezer completely died and the alarm failed to go off.  By the time it was discovered, the products were all at -8 and had been out of temp for hours.  We discarded all of the products.  Turns out that engineering knocked a wire loose when working on the motor and our wireless alarm failed to be noticed by security because someone had closed out the program....Needless to say, I was NOT a happy camper. 

 

This also happened about  8 years ago when someone had turned off the alarm. No one fessed up to it.... When dayshift came in all the products were thawed and freezer felt more like an incubator.  At the time, the freezer was located in another department.  We since have gotten a new lab where we actually have room for all of our equipment!

 

Wow. This is one of the reasons why our automated temperature monitoring system has an alarm point and computer access to monitoring directly in the blood bank. If an alarm goes off it starts playing Rock and Roll by Led Zeppelin (clicked all the way to 11).

Wow. This is one of the reasons why our automated temperature monitoring system has an alarm point and computer access to monitoring directly in the blood bank. If an alarm goes off it starts playing Rock and Roll by Led Zeppelin (clicked all the way to 11).

Yeah, that would be wonderful.  The best ours can do is be set up so that a pop up box shows on the computer.  None of our computers are equipped with speakers (thanks hospital IT!) and in order to see it, the program has to be open and running on the exact computer you are using.  This is why it is supposed to alarm in security.  Email notifications also go out, but if you aren't looking at your email....anyway, it isnt the best system.  Hind sight is 20/20!

We have ours set up (Comark) so it phones the laboratory with a recorded message as to which alarm is sounding. This is challenged weekly.

question: is there a certain temperature and time as a limit before we way it has to be thrown away?

 

When temp increases to the threshold set point (usually 0.5’C off limit), everything gets moved to a different freezer or shipping containers with dry ice. If you get dry ice from your blood supplier your set point may need to be lower to give a transport buffer. If using containers the temp is monitored every four hours. In other words everything is moved before it goes out of temp so nothing is thrown out.