BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO FIVE

    MDR report key: 7851122 · Received September 5, 2018

    Report

    Report Number
    MW5079639
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    July 1, 2018
    Report Date
    August 2, 2018
    Manufacturer
    INTRA PUMP INFUSION SYSTEMS / CANE' S. P. A.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT STATES PUMP SN (B)(4) ((B)(6) 2019) WILL NOT LET HER DO ANYTHING AND EVERY TIME SHE TURNS PUMP ON GIVES HER AN ERROR. PT STATES ERROR IS FOLLOWED BY A NUMBER, BUT UNSURE WHAT THE EXACT ERROR CODE IS. PT STATES SHE DOES NOT HAVE A BATTERY FOR HER PUMP AND CANNOT TURN IT ON, SO UNABLE TO PROVIDE ANY FURTHER REGARDING ERROR. PHARMACY WILL BE SENDING A REPLACEMENT PUMP. NO OTHER INFO IS KNOWN. THE ERROR DID NOT OCCUR WHILE IN USE AND DID NOT CAUSE ANY HARM TO THE PT. THE MALFUNCTIONING PUMP WILL BE RETURNED TO PHARMACY AND PT WILL RECEIVE A REPLACEMENT. DOSE OR AMOUNT: 70.1 NG/KG/MIN, FREQUENCY: 375 MICROL/HR, ROUTE: IV, FROM (B)(6) 2017 TO ONGOING. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685745 CRONO FIVE CRONO FIVE PUMP, INFUSION FRN INTRA PUMP INFUSION SYSTEMS / CANE' S. P. A.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR