BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1040693 · Received May 8, 2008

    Report

    Report Number
    6000001-2008-00312
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 6, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED BY BAXTER FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY INITIALLY REPORTED AN INFUSION PUMP WITH A CONSTANT ALARM IN 2008. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE DEVICE WAS IN PATIENT USE WHEN THE EVENT OCCURRED. ACCORDING TO THE HOSPITAL REP, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFO OR CONTACT WAS AVAILABLE. BAXTER OBTAINED THE FOLLOWING ADDITIONAL INFO FROM THE CUSTOMER ON 05/08/2008. THE BIOMED TECHNICIAN STATED THAT A NURSE SAID THAT THE PUMP STOPPED INFUSING WHILE CONNECTED TO A PATIENT (INOPERABLE) AND WENT INTO CONSTANT ALARM. THE NURSE WAS NOT ABLE TO TURN OFF THE PUMP BY USING THE ON/OFF KEY. THE NURSE REPLACED THE PUMP WITH ANOTHER SINGLE CHANNEL COLLEAGUE PUMP IN ORDER TO CONTINUE THE INFUSION. THE NURSE INFORMED THE BIOMED THAT NO PATIENT INJURY OCCURRED. THE BIOMED TECH SAID THAT HE HAD TO REMOVE THE BATTERIES IN ORDER TO SHUT OFF THE CONSTANT ALARM AND THAT THE BATTERIES WERE WARM TO THE TOUCH. FURTHER INFORMATION WAS OBTAINED FROM THE NURSE MANAGER OF THE MEDICAL/SURGICAL FLOOR ON WHICH THE INCIDENT OCCURRED. THE NURSE MANAGER STATED THAT THE PATIENT WAS RECEIVING A NORMAL SALINE INFUSION AND THAT NO CHANGE OCCURRED TO THE PT'S CONDITION AS A RESULT OF THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1