MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2006-06-29 for FRESENIUS DIALYSIS DELIVERY SYSTEM 2008H NA manufactured by Fresenius Medical Care North America.
[483224]
A dialysis facility reported that a patient gained weight during a hemodialysis treatment. There were reportedly low tmp alarms that had to be reset every 5 minutes. About 3 hrs into the treatment, the patient c/o discomfort and tightness in her arms and fingers. The staff noticed that her face was swollen. Treatment was discontinued. The patient was weighed and her post dialysis weight indicated a weight gain of 5. 7 kg. She was taken to the hospital, dialyzed and discharged the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2006-00004 |
| MDR Report Key | 731685 |
| Report Source | 00,05 |
| Date Received | 2006-06-29 |
| Date of Report | 2006-05-30 |
| Date of Event | 2006-05-26 |
| Date Facility Aware | 2006-05-26 |
| Report Date | 2006-05-30 |
| Date Reported to Mfgr | 2006-05-30 |
| Date Mfgr Received | 2006-05-30 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2006-07-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELVY DIZON, BSN, RN, CNN |
| Manufacturer Street | 2637 SHADELANDS DRIVE |
| Manufacturer City | WALNUT CREEK CA 94598 |
| Manufacturer Country | US |
| Manufacturer Postal | 94598 |
| Manufacturer Phone | 9252950200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | FIL |
| Date Received | 2006-06-29 |
| Model Number | 2008H |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 719973 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | * WALNUT CREEK CA * US |
| Baseline Brand Name | FRESENIUS DIALYSIS DELIVERY SYSTEM |
| Baseline Generic Name | HEMODIALYSIS MACHINE |
| Baseline Model No | 2008H |
| Baseline Catalog No | F002-30 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K921456 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-06-29 |