BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2161357 · Received July 13, 2011

    Report

    Report Number
    6000001-2011-11760
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH AN AIR IN LINE ALARM WAS NOT CONFIRMED OR DUPLICATED BY BAXTER SERVICE PERSONNEL BECAUSE THE DEVICE WAS NOT SENT IN FOR EVALUATION BY THE CUSTOMER. NO CAUSE COULD BE DETERMINED AND NO REPAIRS MADE TO THE DEVICE. A DEVICE HISTORY REVIEW REVEALED NO ABNORMALITIES WERE FOUND DURING MANUFACTURING. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. AT THIS TIME, THE CUSTOMER HAS STATED THAT THE DEVICE WILL BE HELD AT THE FACILITY AND WILL NOT BE RETURNED FOR EVALUATION OR REPAIR. SHOULD THE PUMP BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED AN AIR IN LINE ALARM. IN A FOLLOW-UP PHONE CALL, THE FACILITY BIOMED STATED THAT THIS DID NOT INTERRUPT DELIVERY, BUT OCCURRED WHILE THE NURSE WAS SETTING UP A PIGGYBACK INFUSION IN THE GENERAL PATIENT WARD. THE DEVICE ALARMED FOR AIR IN THE LINE. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS PATIENT INVOLVEMENT, BUT THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. 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