MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-15 for * 2008K manufactured by Fresenius Usa, Inc.
[3563955]
Approximately 30 minutes into dialysis treatment, blood pump on patient's machine stopped working. All blood re-infused and patient moved to another machine where dialysis was resumed without incident. Fresensius medical care contacted. Work order placed with fresenius to fix machine. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3115213 |
| MDR Report Key | 3115213 |
| Date Received | 2013-05-15 |
| Date of Report | 2013-05-15 |
| Date of Event | 2013-05-09 |
| Report Date | 2013-05-15 |
| Date Reported to FDA | 2013-05-15 |
| Date Reported to Mfgr | 2013-05-16 |
| Date Added to Maude | 2013-05-16 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | DIALYZER |
| Product Code | FII |
| Date Received | 2013-05-15 |
| Model Number | 2008K |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS USA, INC |
| Manufacturer Address | 2637 SHADELANDS DR WALNUT CREEK CA 94598 US 94598 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-15 |