MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-08 for BAR CODE READER manufactured by Cerner Corp.
[42213899]
Patient Sequence No: 1, Text Type: N, H10
[42213900]
In (b)(6) 2015, the blood bank encountered an unanticipated problem with scanning expiration dates and unit numbers after implementation of a cerner upgrade resulting in truncated or scrambled numbers. While some of these issues were resolved, the problem remains for (b)(6) numbers and the unit numbers. This occurs randomly and across all pc's and bar-code readers. This can unnecessarily disrupt the provision of care to patients and result in the wasting of blood product. We do not know if this problem can or will extend to blood type bar coding, which may have significant impact for the patient. We have notified cerner of the issues, but have been unable to reproduce the errors. A software update by cerner is available that should address the unit numbers, but not the (b)(4) number problem. On 3/9/2016 the software version was updated to the (b)(6) program on the blood bank computers ((b)(6). ) on 3/12/2016 the bar-code scanners were recalibrated to read slower. Errors still occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5563018 |
| MDR Report Key | 5563018 |
| Date Received | 2016-04-08 |
| Date of Report | 2016-03-16 |
| Date of Event | 2016-02-18 |
| Report Date | 2016-03-01 |
| Date Reported to FDA | 2016-03-01 |
| Date Reported to Mfgr | 2016-03-01 |
| Date Added to Maude | 2016-04-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAR CODE READER |
| Generic Name | BAR CODE READER |
| Product Code | NZH |
| Date Received | 2016-04-08 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERNER CORP |
| Manufacturer Address | 2800 ROCKCREEK PARKWAY KANSAS CITY, MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-08 |