FRESENIUS 2008 BSS

MAUDE Adverse Event Report

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..

Event Text Entries

[21393799] Pt had no complaints pre dialysis, blood pressure 140/80, temp. 98. 7, 5 lbs weight gain. Dialysis was initiated in the usual manner at 300cc blood-flow rate. 810cc ultrafiltration rate. At one hr and 35 min into treatment pt was given 5cc of hypertonic saline iv - bp 110/80 - ultrafiltration rate 790cc 2 hrs 35 mins into treatment the pt requested saline administration because she was feeling poorly. 200 cc saline was given and repeated at 2 hrs and 50 mins for same complaint. Bp was 120/80 ultrafiltration rate was turned off aat pt's request 3 hrs 20 mins into treatment because pt reported not feeeling well - bp 120/80. Treatment was discontinued at 3. 5 hrs as scheduled post treatment blood pressure was 140/80 sitting, 100/80 standing. The pt lost 7lbs during treatmment (pre-weight 132 - post weight 125) target goal for ultrafiltraion calculated at 2750 and set on the machine. Ultrfiltration amount recorded at the end of dialysis was 2503cc. The pt was sent home after treatment without complaints. The machine was removed from service on 11/17/93 because of dialysate flow. Uf pump volume, tmp calibration and machine seeeelf test and presssure holding test were performed by the chief technician. All calibrations and test were satisfactory.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2243621-1994-00013
• MDR Report Key: 14306
• Date Received: 1994-03-18
• Date of Report: 1994-01-25
• Date of Event: 1993-11-15
• 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

Device Details

• Brand Name: FRESENIUS 2008 BSS
• Generic Name: BEDSIDE STATION 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: 14302
• Manufacturer: FRESENIUS USA, INC.
• Manufacturer Address: 2637 SHADELANDS DRIVE WALNUT CREEK CA 94598 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-03-18