MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-18 for FRESENIUS 2008 BSS manufactured by Fresenius Usa, Inc..
[7205]
Pt denied any problems pre dialysis. Temperature not done. Blood pressure 140/80 weight 138 pounds - gain 4 lbs. Dialysis was initiated at 400 blood flow-site 460cc ultrafiltration rate with ultrafiltration goal of 1400cc. One hr 55 min into dialysis pt's blood pressure dropped to 80/60. Pt was given 200cc of saline and 50cc mannitol. The pt's blood pressure 35 min prior tp this was 90/70 but no other interventions were done. At 2 hrs 20 mins of treatment pt was given an additional 200cc of saline for blood pressure 100/70. Pt dialysis was terminated 10 min early because she felet sick. Post dialysis blood pressure 130/70. Temperature 97. 2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1994-00014 |
| MDR Report Key | 14298 |
| Date Received | 1994-03-18 |
| Date of Report | 1994-01-26 |
| Date of Event | 1993-11-17 |
| Date Facility Aware | 1994-01-26 |
| Report Date | 1994-02-01 |
| Date Reported to FDA | 1994-02-18 |
| Date Reported to Mfgr | 1994-02-01 |
| Date Added to Maude | 1994-06-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRESENIUS |
| Generic Name | BEDSIDE STATION DIALYSIS MACHINE |
| Product Code | FLC |
| Date Received | 1994-03-18 |
| Model Number | 2008 BSS |
| Operator | PERSONAL CARE ASSISTANT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14293 |
| Manufacturer | FRESENIUS USA, INC. |
| Manufacturer Address | 2637 SHADELANDS DRIVE WALNUT CREEK CA 94598 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-18 |