BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO FIVE SYRINGE 20ML INTRA PUMP

    MDR report key: 9910436 · Received March 31, 2020

    Report

    Report Number
    MW5094000
    Event Type
    Malfunction
    Date Received
    March 31, 2020
    Date of Event
    March 19, 2020
    Report Date
    March 19, 2020
    Manufacturer
    CANE' S.P.A
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES HIS CRONO PUMP SN (B)(4) FELL AND HIT HIS DRESSER AND STARTED TO ALARM FOR OCCLUSION. HE REPLACED THE BATTERIES AND PUMP THEN GAVE HIM AN ERROR 5 MESSAGE. ERROR DID NOT OCCUR WHILE PUMP WAS IN USE AND DID NOT CAUSE ANY HARM TO THE PATIENT. PHARMACY NO LONGER CARRIES PUMP AND DOES NOT HAVE A REPLACEMENT TO SEND HIM. PATIENT WILL RETURN PUMP BACK TO THE PHARMACY. PATIENT HAS AN EXTRA (THIRD PUMP) ON HAND AND WILL HAVE 2 PUMPS TO ROTATE BETWEEN. INTRA PUMP INFUSION SYSTEMS. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365444 CRONO FIVE SYRINGE 20ML INTRA PUMP PUMP, INFUSION FRN CANE' S.P.A 3370.5

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR