BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRONO 5 PUMP

    MDR report key: 6499815 · Received April 14, 2017

    Report

    Report Number
    MW5069136
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    April 8, 2017
    Report Date
    April 12, 2017
    Manufacturer
    CANE' SPA
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED IN AND HER CRONO 5 PUMP GAVE OCCLUSION ERRORS ON 2 DIFFERENT OCCASIONS. HAPPENED FIRST ON (B)(6), AND THERE WAS NO OCCLUSION BUT WHEN SHE CHECKED THE TUBING AND MOVED IT AROUND, THE ALARM WENT OFF, AND THE PUMP WAS OK. SHE USED THE PUMP AGAIN ON (B)(6), AND WHEN PRIMING THE PUMP, IT GAVE THE OCCLUSION ERROR AGAIN, AND SHE STATED THERE WERE NO OCCLUSIONS. THE PATIENT DID NOT MISS ANY OF HER REMODULIN DOSE. THE SERIAL NUMBER OF THE BAD PUMP IS 306614. DOSE OR AMOUNT: 6ML (137.7NG/GK/MIN. FREQUENCY: EVER. ROUTE: CONTINUOUS. DATES OF USE: FROM (B)(6) 2017 TO PRESENT. DIAGNOSIS OR REASON FOR USE: I27.0 PRIMARY PULMONARY HYPERTENSION. REPORTED TO (B)(6) BY PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277515 CRONO 5 PUMP INFUSION PUMP FRN CANE' SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR