MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-01-11 for FRESENIUS DIALYSIS DELIVERY SYSTEM 2008K NA manufactured by Fresenius Medical Care North America.
[213588]
Reports of ultrafiltration problems that were observed over several months were received from the manufacturer's affiliate in canada on 12/14/2001. Reports suggest excess fluid was removed during hemodialysis treatments. Information provided was very limited. There was no reported serious injury. The patient had low blood pressure after one hour. Reported ultrafiltrate removed was 1. 8 kg in one hour. The machine showed that 0. 4 kg. Was removed. Pressure holding test was performed and passed. On-line pressure holding test was not activated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2002-00005 |
| MDR Report Key | 371726 |
| Report Source | 07 |
| Date Received | 2002-01-11 |
| Date of Report | 2001-12-14 |
| Date of Event | 2001-12-05 |
| Date Facility Aware | 2001-12-05 |
| Report Date | 2001-12-14 |
| Date Reported to Mfgr | 2001-12-14 |
| Date Mfgr Received | 2001-12-14 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2002-01-18 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | 2002-01-11 |
| Model Number | 2008K |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 360853 |
| Manufacturer | FRESENIUS MEDICAL CARE NORTH AMERICA |
| Manufacturer Address | 2637 SHADELANDS DR. WALNUT CREEK CA 94598 US |
| Baseline Brand Name | FRESENIUS DIALYSIS DELIVERY SYSTEM |
| Baseline Generic Name | HEMODIALYSIS MACHINE |
| Baseline Model No | 2008K |
| Baseline Catalog No | F002-40 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K994267 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-01-11 |