BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORB SYSTEM

    MDR report key: 6717 · Received September 8, 1993

    Report

    Report Number
    6717
    Event Type
    Malfunction
    Date Received
    September 8, 1993
    Manufacturer
    ORGANON TEKNIKA CORP.
    Product Code
    FKT
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORB SYSTEM DIALYSIS MACHINE FKT ORGANON TEKNIKA CORP. URS-D

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other