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..
[10497]
Pt denied complaints pre-dialysis. Temp. 97. 6, bp 120/70 weight 138 lbs,, gained 2 lbs. Dialysiis was initiated in the usual manner at 300 blood flow rate. 470 ultraaafiltration gaaol 1400cc. 2hrs 5 mins into dialysis pt's bp was 90/60. Pt was lethargicand 200cc normal saline was given. Bp remained low - 80/60-90/60 and dialysis wa terminated at 2hrs 35 mins because blood pressure did not improve in spite of an additional 550cc saline. Pt also reported cramping. Post dialysis temp. 98. 0, bp 120/70, post weight 135 - loss 3 lbs. The pt was asymptomatic post treatment and was sent home. This was the second incident on this machine that involved this pt. It was the third incident on the machine since 11/15/93. The chieeef technician removed the machine from use. The u. F. Rate was recalibrated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1994-00015 |
| MDR Report Key | 14307 |
| Date Received | 1994-03-18 |
| Date of Report | 1994-01-26 |
| Date of Event | 1993-11-22 |
| Date Facility Aware | 1994-01-25 |
| 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 2008 BSS |
| Generic Name | BEDSIDEE STATIOIN DIALYSIS MACHINE |
| Product Code | FLC |
| Date Received | 1994-03-18 |
| Model Number | 2008 BSS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14303 |
| 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 |