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FDA reportable Question

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At our facility, we had two units that were crossmatched for a patient. The tech issued the first unit in computer but gave the 2nd unit to the nurse for transfusion. The nurse transfused the 2nd unit but the first unit was showing issued in the computer. The unit and paperwork all matched and the correct patient received the unit without harm but am I required to report to FDA due to computer discrepancy of wrong unit showing issued in computer? We corrected the computer part and the patient received the other unit of blood the next day. I did counsel the tech and show him how to issue by unit number so that this will not happen again. Please give me your thoughts.

 

 

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Yep, any time a "wrong unit" is out of your control, that is issued to nursing, that's reportable.  Doesn't matter if it's for the "right" patient.  If a mistake leaves the blood bank, it's reportable.

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Hmm, not sure.

We have not been able to solve our "failure to issue in the computer" dilemma, but one thing we added was capturing all of the computer steps on a paper that is saved in the blood bank.  We save a paper that has a sticker from the unit, we date / time stamp it and initial it.  Our SOP says that the initials indicate that all of the safety / suitability checks have been done on the unit.

We still investigate these events and try to resolve them, but those are not reported to the FDA.  Nothing went wrong except for some record keeping.

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Are you selecting from a list in the computer?

If so, can you make it a requirement that the unit has to be bar code scanned into the issue program?

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1 hour ago, rravkin@aol.com said:

Is there a way to ask the FDA directly? Does the FDA offer accessible public information as to the specifics of what is and is not reportable?

Yes, they are amazingly receptive and helpful  I've had many emails and several phone calls with them.  Always helpful.

(240) 402-9160

bp_deviations@fda.hhs.gov

hctp_deviations@fda.hhs.gov

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On 9/9/2017 at 8:05 AM, rravkin@aol.com said:

Is there a way to ask the FDA directly? Does the FDA offer accessible public information as to the specifics of what is and is not reportable?

Please let us know the outcome. Thank you

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Also, if you report and it is not a reportable issue, they will tell you that and it is removed.  So always better to err on the side of caution and have them reject, rather than miss reporting.

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The wrong unit  was issued in the computer and left the Blood Bank. It is FDA reportable.  It does help if you can scan the unit itself when issuing. Some computers also print a form when issuing that can be checked with the unit prior to the unit leaving the Blood Bank. 

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I would say  - not reportable to the FDA but definitely needs to be documented with an occurrence and the steps reviewed for opportunities to improve the process.  Not reportable to the FDA because the unit was designated and acceptable for transfusion to the patient.  I assume the review process of inspecting the unit, documenting when it was issued, when the TX was started, any adverse events associated with transfusions, completion of the TX within the required time limit, etc was correct and documented.  If the incorrect selection of unit 2 instead of unit 1 in the computer led to issuing an unsuitable unit, definitely reportable to the FDA or your State agency if they assume that role.  The same thing happens frequently when a unit is issued but not saved in the computer (the saved button is not clicked) so it is not issued but stays allocated, to be corrected when the transfusion documents are accounted.   

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8 hours ago, Marianne said:

Also, if you report and it is not a reportable issue, they will tell you that and it is removed.  So always better to err on the side of caution and have them reject, rather than miss reporting.

We report about 75 a year.  FDA rejects 2 or 3 a year.

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15 hours ago, Cliff said:

We report about 75 a year.  FDA rejects 2 or 3 a year.

Is this a typo or do you seriously have that many FDA reportables per year!?! From ONE transfusion service?!?

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1 hour ago, lpregeno said:

Is this a typo or do you seriously have that many FDA reportables per year!?! From ONE transfusion service?!?

Nope, not a typo.  We're pretty big, plus we have a donor center.

2011 - 73
2012 - 57
2013 - 75
2014 - 70
2015 - 65
2016 - 41

We've changed the way we issue products, so our failure to issues are mostly not reportable, that's why we've had the decrease in the past couple of years.

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This is FDA reportable.  Multiple reasons why: loss of control over the correct product, failure to follow your SOP, and the computer (most of them) runs final safety checks upon issuing in the computer.  These are always slightly annoying to report, but as Marianne said better to err on the side of caution.

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