BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1940055 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06297
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP OF "OVER-INFUSED DURING PATIENT USE" WAS NOT CONFIRMED NOR DUPLICATED DURING PRODUCT EVALUATION. HOWEVER, BAXTER QUALITY ENGINEERING DETERMINED THAT THIS DEVICE UNDER-INFUSED, WHICH WAS CAUSED BY A DEFECTIVE PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED TO CORRECT THE CONDITION OF UNDER-INFUSION. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90. 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). 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 REPORTED A COLLEAGUE INFUSION PUMP WHICH OVERINFUSED DURING PATIENT USE IN THE EMERGENCY ROOM. ACCORDING TO THE FACILITY REPRESENTATIVE, THE PUMP WAS INFUSING CARDIZEM AND SODIUM CHLORIDE AT THE TIME OF THE EVENT. THE PUMP WAS SET TO 10MG PER HOUR, BUT IT WAS LATER DISCOVERED THAT THE MACHINE HAD SWITCHED TO PRIMARY RATE OF 1200MG PER HOUR AND 200MG OF THE DRUG HAD INFUSED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 CARDIZEM| SODIUM CHLORIDE