BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM WIRELEES BATTERY MODULE B

    MDR report key: 2864667 · Received November 9, 2012

    Report

    Report Number
    1314492-2012-00404
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 11, 2012
    Manufacturer
    BASXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY SIGMA WITH THE SPECTRUM PUMP THAT WAS ATTACHED TO THE DEVICE AT THE TIME OF THE EVENT (S/N (B)(4)) AND FOUND THE PUMP TO HAVE AN INTERMITTENT BATTERY CONNECTION DUE TO A FAILED WIRELESS MODULE. THIS MAY CAUSE AN IMPROPER SHUTDOWN WHILE OPERATING ON BATTERY POWER ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP SHUT OFF WHILE INFUSING (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). THE CUSTOMER STATED THAT WHEN PUMP WAS TOUCHED (NOT THE ON/OFF DEY) THE PUMP DISPLAYED "IMPROPER SHUTDOWN." IT EAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM WIRELEES BATTERY MODULE B WIRELESS BATTERY MODULE FRN BASXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1