MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-26 for FRESENIUS DIALYSIS DELIVERY SYSTEM 2008K NA manufactured by Fresenius Medical Care North America.
[21294344]
It was reported to fresenius medical care that a pt expired about one hour into a hemodialysis treatment, investigation is on-going.
Patient Sequence No: 1, Text Type: D, B5
[21354068]
Supplemental report will be submitted upon receipt of additional info. Mfr complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2012-00017 |
| MDR Report Key | 2555996 |
| Report Source | 06 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-03-14 |
| Date of Event | 2012-03-14 |
| Date Facility Aware | 2012-03-14 |
| Report Date | 2012-04-24 |
| Date Reported to Mfgr | 2012-03-14 |
| Date Mfgr Received | 2012-03-14 |
| Date Added to Maude | 2012-05-03 |
| 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 | 3 |
| Manufacturer Contact | JERRY SUCCURO, CCHT, MA |
| Manufacturer Street | 2637 SHADELANDS DR. |
| Manufacturer City | WALNUT CREEK CA 94598 |
| Manufacturer Country | US |
| Manufacturer Postal | 94598 |
| Manufacturer Phone | 9252950200 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS DIALYSIS DELIVERY SYSTEM |
| Generic Name | HEMODIALYSIS MACHINE |
| Product Code | FII |
| Date Received | 2012-04-26 |
| Model Number | 2008K |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | WALNUT CREEK CA 94598 US 94598 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2012-04-26 |