MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-11-20 for HCLL TRANSFUSION 4.7 manufactured by Mediware Information Systems Inc. Headquarters.
[5131521]
Hcll allowed an a positive red blood cell to be electronically crossmatched to an o positive patient. Tech erroneously selected a+ rbc. Hcll allowed selection and recorded a compatible xm with no exception or warnings. Unit displays in product fulfillment as not trdy. Blood was not issued to patient or transfused. The error was caught by redundant systems within the software. To date, efforts to duplicate the error with patient or others have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006129391-2014-00002 |
| MDR Report Key | 4308209 |
| Report Source | 06 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-11-19 |
| Date of Event | 2014-11-13 |
| Date Added to Maude | 2014-12-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR JON MOECKEL |
| Manufacturer Street | 11711 WEST 79TH STREET |
| Manufacturer City | LENEXA KS 662140000 |
| Manufacturer Country | US |
| Manufacturer Postal | 662140000 |
| Manufacturer Phone | 9133071051 |
| Manufacturer G1 | MEDIWARE INFORMATION SYSTEMS INC. HEADQUARTERS |
| Manufacturer Street | 11711 WEST 79TH STREET |
| Manufacturer City | LENEXA KS 66214000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 66214 0000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HCLL TRANSFUSION 4.7 |
| Generic Name | HCLL |
| Product Code | MMH |
| Date Received | 2014-11-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIWARE INFORMATION SYSTEMS INC. HEADQUARTERS |
| Manufacturer Address | 11711 WEST 79TH STREET LENEXA KS 66214 US 66214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-20 |