BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2180222 · Received July 27, 2011

    Report

    Report Number
    6000001-2011-14809
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A DAMAGED BATTERY WAS NOT CONFIRMED NOR REPRODUCED DURING SERVICE EVALUATION. UPON REVIEW OF THE EVENT HISTORY LOG, THE QUALITY ENGINEER HAS CONFIRMED THE REPORTED CONDITION AS A BATTERY ISSUE. THE ASSIGNABLE CAUSE WAS A BATTERY LOW ALERT. NO REPAIRS WERE PERFORMED FOR THE REPORTED CONDITION. ADDITIONAL INFORMATION: THE USER SOFTWARE VERSION IS 5.09.90. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. HOWEVER, DURING PREVIOUS SERVICE THE BATTERIES AND HARNESS WERE REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY. THIS CONDITION WAS FOUND UPON POWER UP OF THE DEVICE IN THE BIOMED SERVICE AREA. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1