BLUE SPRINGS WP-280R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-03 for BLUE SPRINGS WP-280R manufactured by Blue Springs Corp..

Event Text Entries

[27130] Pt expired following myocardial infarction and cardiac arrest approx 90 mins after a hemodialysis treatment. The pt's dialysis was terminated early due to a suspected pyrogen reaction. Subsequent investigation indicates that the reverse osmosis system (ro) used to treat the water for reprocessing dialyzers had a ruptured membrane. Reverse osmosis pump had failed, and pieces of the broken pump were found in the ruptured reverse osmosis membrane. It is unknown as to whether there is any association between the suspected pyrogen reaction and the pt death. Seven other pts also experienced suspected pyrogen reactions during the same morning: six of whom recovered and left the facility that morning; the seventh pt was hospitalized overnight for observation and was discharged the next day having recovered with no intervention.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 34327
• MDR Report Key: 34327
• Date Received: 1996-06-03
• Date of Report: 1996-06-03
• Date of Event: 1996-05-17
• Date Facility Aware: 1996-05-17
• Report Date: 1996-06-03
• Date Reported to FDA: 1996-06-03
• Date Reported to Mfgr: 1996-06-03
• Date Added to Maude: 1996-07-24
• 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: 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: BLUE SPRINGS
• Generic Name: REVERSE OSMOSIS SYSTEM
• Product Code: JRS
• Date Received: 1996-06-03
• Model Number: WP-280R
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 11 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 35686
• Manufacturer: BLUE SPRINGS CORP.
• Manufacturer Address: ENCINO CA 91436 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1996-06-03