BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO 5 SYRINGE PUMP

    MDR report key: 6796947 · Received August 12, 2017

    Report

    Report Number
    MW5071582
    Event Type
    Malfunction
    Date Received
    August 12, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 8, 2017
    Manufacturer
    CANE SPA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT DROPPED HER CRONO 5 SYRINGE PUMP IN WATER WHILE ON VACATION. PT DID NOT MISS ANY MEDICATION NOR HAVE ANY ADVERSE EVENTS. THE PATIENT WILL SEND BACK THE DAMAGED PUMP. DID NOT KNOW SERIAL # OR EXPIRATION DATE. PATIENT DID NOT PROVIDE CONSENT TO BE CONTACTED BY MANUFACTURER. NO MORE INFORMATION GIVEN. REPORTED TO (B)(6) BY: PATIENT CAREGIVER. DOSE OR AMOUNT: 44NG/KG/MON, FREQUENCY: CONTINUOUSLY, ROUTE: IV. DATES OF USE: (B)(6) 2014 TO PRESENT. DIAGNOSIS OR REASON FOR USE: I27.0 PRIMARY PULMONARY HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570820 CRONO 5 SYRINGE PUMP PUMP, INFUSION FRN CANE SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR