REDY 2000 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-04 for REDY 2000 N/A manufactured by Organon Teknika.

Event Text Entries

[20437487] 4/28/92 floor nurse called maintenance-reported the redy 2000 had a malfunction. Bio-med technician responded and reported lowflow alarms during priming mode. Called manufacturer and reported malfunction. 4/29/92 organon-teknika field engineer came and replaced flow transducer and checked out system. Patient was an 85 year old white female who was hospitalized with chf and renal failure. Dialysis machine would not function out of priming mode. Patient ultimately transferred to another facility for dialysisdevice not labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-apr-92. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, performance tests performed. Results of evaluation: component failure, transducer. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device repaired and put back in service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1077
• MDR Report Key: 1077
• Date Received: 1992-07-04
• Date of Report: 1992-04-30
• Date of Event: 1992-04-28
• Date Facility Aware: 1992-04-28
• Report Date: 1992-04-30
• Date Reported to FDA: 1992-04-30
• Date Reported to Mfgr: 1992-04-28
• Date Added to Maude: 1992-08-18
• 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: REDY 2000
• Generic Name: DIALYSIS SYSTEM
• Product Code: FLC
• Date Received: 1992-07-04
• Model Number: 2000
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: CRH #3518
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAR-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1033
• Manufacturer: ORGANON TEKNIKA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-04