REDY SORBENT MACHINE #1 SS-D UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-02 for REDY SORBENT MACHINE #1 SS-D UNKNOWN manufactured by Organon Teknika.

Event Text Entries

[1737] The patient was dialyzed by an acutronics inc. Nurse utilizing the redy sorbent machine. The patient had a predialysis sodium level of 142 meq/1. The post dialysis sodium level was 180 meq/1. The patient required another dialysis. The equipment is owned by acutronics, inc. And is in their possessioninvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2777
• MDR Report Key: 2777
• Date Received: 1993-02-02
• Date of Report: 1992-07-10
• Date of Event: 1992-06-29
• Date Facility Aware: 1992-06-29
• Report Date: 1992-07-10
• Date Reported to FDA: 1992-07-10
• Date Reported to Mfgr: 1992-07-10
• Date Added to Maude: 1993-03-27
• 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 SORBENT MACHINE #1
• Generic Name: UNKNOWN
• Product Code: FKT
• Date Received: 1993-02-02
• Model Number: SS-D
• Catalog Number: UNKNOWN
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2603
• Manufacturer: ORGANON TEKNIKA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-02-02