BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2082571 · Received April 27, 2011

    Report

    Report Number
    2016493-2011-00297
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NOTIFIED BY PHARMACIST ON (B)(4) 2011 THAT THE DEVICE WAS SEQUESTERED IN PHARMACY AND THAT IT WAS DETERMINED THAT THE DISCONNECTION OCCURRED BECAUSE OF USER HANDLING. NO PRODUCT RETURN IS EXPECTED. CUSTOMER DECLINED TO RETURN ANY DEVICES AND DECLINED AN INVESTIGATION BY CAREFUSION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHILE A NURSE WAS MOVING A PC UNIT AND 4 MODULES, THE LEFT TWO MODULES (LOOKING AT THE PUMP) ALERTED COMMUNICATION ERROR AND THE RED LIGHT BLINKED ON TOP OF EACH MODULE. THE TWO LEFT MODULES STOPPED INFUSING WHILE THE RIGHT MODULES KEPT RUNNING. THE REPORTER INDICATED THERE WAS A SUSPICION THAT THE MODULES WERE DISCONNECTING WHEN MANIPULATED. NO ADDITIONAL PATIENT OR EVENT INFORMATION PROVIDED. NO PATIENT HARM REPORTED AND NO MEDICAL INTERVENTION REQUIRED.

    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 UNKNOWN ALARIS PC UNIT: S/N UNKNOWN| 3 ALARIS PUMP MODULES: S/N UNKNOWN