MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-04 for HCLL TRANSFUSION 2013 R2 manufactured by Mediware Information Systems Inc. Headquarters.
[5252489]
Hcll transfusion 2013 r2 interface was configured by the user facility from the grifols instrument. The engine between the instrument and hcll sent a result with blood group a pos. The user experienced the incorrect reporting, as the patient had a previous blood type result of o neg. The manual result was exported from the grifols instrument and received as o neg by the hcll application. Blood was not issued to the patient or transfused. The error was caught by redundant systems within the software.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006129391-2014-00003 |
| MDR Report Key | 4324846 |
| Report Source | 06 |
| Date Received | 2014-12-04 |
| Date of Report | 2014-12-03 |
| Date of Event | 2014-11-04 |
| Date Mfgr Received | 2014-11-04 |
| Device Manufacturer Date | 2014-06-26 |
| Date Added to Maude | 2014-12-17 |
| 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 66214 |
| Manufacturer Country | US |
| Manufacturer Postal | 66214 |
| Manufacturer Phone | 9133071051 |
| Manufacturer G1 | MEDIWARE INFORMATION SYSTEMS INC. HEADQUARTERS |
| Manufacturer Street | 11711 WEST 79TH STREET |
| Manufacturer City | LENEXA KS 66214 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 66214 |
| Single Use | 0 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HCLL TRANSFUSION 2013 R2 |
| Generic Name | HCLL TRANSFUSION 2013 |
| Product Code | MMH |
| Date Received | 2014-12-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2014-12-04 |