BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRONO 5 PUMP

    MDR report key: 7057372 · Received November 24, 2017

    Report

    Report Number
    MW5073538
    Event Type
    Injury
    Date Received
    November 24, 2017
    Date of Event
    September 30, 2017
    Report Date
    September 30, 2017
    Manufacturer
    INTRA PUMP INFUSION SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTED HER CRONO 5 PUMP SN (B)(4) DUE (B)(6) 2018 FOR IV REMODULIN WENT BLANK WOULD NOT WORK EVEN WITH BATTERY REPLACEMENT. REPLACED PUMP. PT USED BACK UP AND HAD NO SE FROM PUMP MALFUNCTION. DOSE OR AMOUNT: 1, FREQUENCY: CONTINUOUS, ROUTE: IV. DATES OF USE: FROM (B)(6) 2017 TO (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836878 CRONO 5 PUMP CRONO 5 PUMP FRN INTRA PUMP INFUSION SYSTEMS 3306.15

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention