BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDY SORBENT MACHINE #1

    MDR report key: 2777 · Received February 2, 1993

    Report

    Report Number
    2777
    Event Type
    Injury
    Date Received
    February 2, 1993
    Date of Event
    June 29, 1992
    Report Date
    July 10, 1992
    Manufacturer
    ORGANON TEKNIKA
    Product Code
    FKT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDY SORBENT MACHINE #1 UNKNOWN FKT ORGANON TEKNIKA SS-D N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other