BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10242987 · Received July 7, 2020

    Report

    Report Number
    3012307300-2020-06695
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Report Date
    August 17, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. NO EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS FOUND. DURING THE EVALUATION OF THE DEVICE, NO FAULT WAS FOUND WITH THE PUMP. THREE DELIVERY TESTS WERE PERFORMED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 0

    ORACLE RO 1072008: FAIL ACCURACY - 12.45%. ADDITIONAL INFORMATION RECEIVED ON 26-JUN-2020: NO PATIENT INVOLVEMENT. EVENT DETAILS UPDATED.

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE WAS RECEIVED IN DECENT PHYSICAL CONDITION. THE DEVICE HAD A CRACKED BOTTOM ASE IN THE BATTERY BAY AND A RIGHT PLUNGER CASE. NO EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS FOUND. DURING THE EVALUATION OF THE DEVICE, THE SPEAKER WAS MAKING A RATTLING NOISE DURING THE POWER UP PROCESS AND TESTING THE SPEAKER. THERE WAS DEBRIS FOUND STUCK INSIDE THE SPEAKER. THIS WAS LIKELY CAUSED BY NORMAL WEAR AS THE PUMP IS OVER 14 YEARS OLD. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION SYRINGE PUMP PRESENTED WITH AN AUDIBLE ALARM. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705183 CADD PUMP, INFUSION FRN ST PAUL 21-6400-51

    Patients

    Seq Age Sex Outcome Treatment
    1