MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2002-02-15 for FRESENIUS DIALYSIS DELIVERY SYSTEM 2008K NA manufactured by Fresenius Medical Care-north America.
[241660]
Fresenius medical care canada, inc. Reported that there was excessive fluid removed durign a hemodialysis treatment. The patient became hypotensive and c/o severe headache during treatment. 1,400 ml. Of saline was given. Based on the pre and post weights reported, saline given and what the machine indicated was removed, there was a weight loss variance of approximately 3kg. There was no serious injury or illness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2002-00013 |
| MDR Report Key | 378045 |
| Report Source | 05,07 |
| Date Received | 2002-02-15 |
| Date of Report | 2002-01-22 |
| Date of Event | 2001-12-23 |
| Date Facility Aware | 2001-12-23 |
| Report Date | 2002-01-22 |
| Date Reported to Mfgr | 2001-01-22 |
| Date Mfgr Received | 2002-01-22 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2002-02-25 |
| 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 |
| 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 | 2002-02-15 |
| Model Number | 2008K |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 367092 |
| 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 | 2002-02-15 |