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.
[254772]
Fresenius medical care canada, inc. Reported that there was excessive fluid removed during a hemodialysis treatment. The machine gave a high arterial pressure alarm. The pt became hypotensive 20 minutes into the treatment and was given 200cc of saline. The nurse noticed that the ultra-filtration (uf) rate was higher than expected based on the uf goal and uf time. Uf goal was 600 ml. Uf time was 3:10, ultra-filtration rate was 1,630 ml/hr, and uf removed was 568 ml. Treatment was continued and completed with the uf turned off. The pt rec'd add'l saline during treatment. There was no serious injury or illness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2002-00014 |
| MDR Report Key | 378006 |
| Report Source | 05,07 |
| Date Received | 2002-02-15 |
| Date of Report | 2002-01-24 |
| Date of Event | 2002-01-21 |
| Date Facility Aware | 2002-01-21 |
| Report Date | 2002-01-24 |
| Date Reported to Mfgr | 2001-01-24 |
| Date Mfgr Received | 2002-01-24 |
| 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 |
| Remedial Action | OT |
| 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 | 1 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 367053 |
| Manufacturer | FRESENIUS MEDICAL CARE-NORTH AMERICA |
| Manufacturer Address | 2637 SHADELANDS DRIVE 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 |