MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-04-10 for FRESENIUS DIALYSIS DELIVERY SYSTEM 2008H NA manufactured by Fresenius Medical Care-north America.
[1196148]
A dialysis facility reported that a pt gained weight during a hemodialysis treatment. The goal was set for 2. 5 kg. But his post wt increased. Another machine was set up for pure ultrafiltration (uf) for 2 hrs. With a uf rate of 2l/hr. There was no serious injury.
Patient Sequence No: 1, Text Type: D, B5
[8380008]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937457-2009-00003 |
| MDR Report Key | 1399355 |
| Report Source | 99 |
| Date Received | 2009-04-10 |
| Date of Report | 2009-03-12 |
| Date of Event | 2009-03-12 |
| Date Facility Aware | 2009-03-12 |
| Report Date | 2009-03-12 |
| Date Reported to Mfgr | 2009-03-12 |
| Date Mfgr Received | 2009-03-12 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2009-10-22 |
| 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 | ELVY DIZON, BSN, RN, CNN |
| Manufacturer Street | 2637 SHADELANDS DR |
| Manufacturer City | WALNUT CREEK CA 94598 |
| Manufacturer Country | US |
| Manufacturer Postal | 94598 |
| Manufacturer Phone | 9252950200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS DIALYSIS DELIVERY SYSTEM |
| Generic Name | HEMODIALYSIS MACHINE |
| Product Code | FKP |
| Date Received | 2009-04-10 |
| Model Number | 2008H |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS MEDICAL CARE-NORTH AMERICA |
| Manufacturer Address | WALNUT CREEK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-10 |