BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2221922 · Received August 17, 2011

    Report

    Report Number
    9616066-2011-00465
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 26, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER CALLED WITH REPORT THAT PRIMARY TUBING WOULD NOT INFUSE. CLINICIAN REPORTED THAT THE EVENT WAS A DEXTROSE 5% PRIMARY INFUSION WITH ATTACHED SECONDARY INFUSION OF ELOXATIN (OXALIPLATIN INJECTION). THE SET UP WAS WITH THE PRIMARY LOWERED ON THE HANGER. THE SECONDARY INFUSION DID NOT INFUSE AND THE FLUID INFUSED FROM THE PRIMARY. CLINICIAN REPORTED, THE SETS ARE PRIMED IN PHARMACY. NO ADDITIONAL COMPONENTS ARE ADDED TO THE END OF THE SECONDARY TUBING. THE INFUSION WAS SWITCHED TO NEW IV SETS AND COMPLETED. THE RN FROM THE OUTPATIENT INFUSION CENTER STATED THAT THE CLAMP WAS OPEN ON THE SECONDARY SET AND WAS HUNG SUPERIOR TO THE PRIMARY. THE SIZE OF SECONDARY BAG IS UNK. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2420-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK BAXTER SECONDARY SET: MODEL # 2C7462/LOT UNK| ALARIS PC UNIT: S/N UNK| ALARIS PUMP MODULE: S/N UNK