BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2082561 · Received April 27, 2011

    Report

    Report Number
    2016493-2011-00294
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS RECEIVED. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE 2 CHANNELS ON THE RIGHT SIDE OF THE PC UNIT WERE HOT TO THE TOUCH AND EMITTING A "HOT, BURNING" ODOR. UPON FURTHER INSPECTION, THE MALE IUI CONNECTOR ON SN (B)(4) AND THE FEMALE IUI CONNECTOR ON SN (B)(4) WERE MELTED. STATED, THE 2 MODULES ON THE RIGHT SIDE WERE NOT POWERED ON OR INFUSING AT THE TIME OF THE EVENT. THE PUMP MODULE, SN (B)(4) ON THE LEFT SIDE OF THE PC UNIT WAS POWERED ON, INFUSING (MEDICATION UNKNOWN) WITH NO ISSUES REPORTED. NO PATIENT OR STAFF HARM REPORTED. THE SYSTEM (PC UNIT AND 3 PUMP MODULES) WAS REPLACED AND THE INFUSION RESTARTED. THE POWER OUTLET IN THE PATIENT'S ROOM WAS EVALUATED BY THE HOSPITAL'S MAINTENANCE STAFF AND NO ISSUES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)