SORB SYSTEM URS-D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-09-08 for SORB SYSTEM URS-D manufactured by Organon Teknika Corp..

Event Text Entries

[3889] Dialysate flow pump on dialysis machine quit functioning during a pt treatment. The treatment had been in progress for 40-45 mins. The treatment was discontinued. The pt had no ill effects. The physician was aware. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-93. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: telemetry failure, none or unknown. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6717
• MDR Report Key: 6717
• Date Received: 1993-09-08
• Date Added to Maude: 1993-10-11
• Event Key: 0
• Report Source Code: User Facility 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: 0
• Initial Report to FDA: 0
• 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: SORB SYSTEM
• Generic Name: DIALYSIS MACHINE
• Product Code: FKT
• Date Received: 1993-09-08
• Model Number: URS-D
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6401
• Manufacturer: ORGANON TEKNIKA CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-09-08