MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-19 for NEW R-1 BLOOD DONATION MACHINE manufactured by .
[1235250]
Attempted to make routine r-1 blood donation. Donation aborted before completion because operators not familiar with recently-installed machine. Cannot prove this. This opinion based on: comments before being hooked up to machine to effect that she was only person in facility familiar with new machines; puzzled looks and dithering from handful of people responding to alarms from machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012861 |
| MDR Report Key | 1488113 |
| Date Received | 2009-06-19 |
| Date of Report | 2009-06-19 |
| Date of Event | 2009-06-17 |
| Date Added to Maude | 2009-10-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NEW R-1 BLOOD DONATION MACHINE |
| Product Code | KST |
| Date Received | 2009-06-19 |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-19 |