BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO 5

    MDR report key: 8128969 · Received December 3, 2018

    Report

    Report Number
    MW5081801
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 15, 2015
    Report Date
    November 15, 2015
    Manufacturer
    INTRA PUMP INFUSION SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER PATIENT - A FEW DAYS AGO HER TUBING GOT CAUGHT WHEN SHE WAS GETTING IN THE CAR AND HER CRONO 5 PUMP SN (B)(4) FELL ON THE GROUND AND THE CASING CAME OFF OF IT AND IT ERRORED THOUGH PATIENT DID NOT KNOW THE ERROR. PATIENT SWITCHED TO BACKUP PUMP AND IS DOING FINE. NO HARM TO PATIENT. PATIENT GETTING A REPLACEMENT PUMP TOMORROW AND WILL RETURN THE BROKEN PUMP TO US. NO FURTHER INFORMATION AVAILABLE. REPORTED TO (B)(4) BY: PATIENT/CAREGIVER. DOSE OR AMOUNT: REMODULIN 82NG/KG/MIN. FREQUENCY: CONTINUOUSLY. ROUTE: INTRAVENOUSLY. DATES OF USE: FROM UNKNOWN TO ONGOING. DIAGNOSIS OR REASON FOR USE: PRIMARY PULMONARY HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962964 CRONO 5 PUMP INFUSION FRN INTRA PUMP INFUSION SYSTEMS 3375.15

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR