BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1823040 · Received September 1, 2010

    Report

    Report Number
    6000001-2010-02918
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. DEVICE EVALUATION COULD NOT CONFIRM THE REPORTED CONDITION OF NOT ALARMING AT ALL. THE ROOT CAUSE COULD NOT BE DETERMINED AND NO REPAIRS WERE PERFORMED AS THIS IS A STAY-IN DEVICE. SERVICE HISTORY REVIEW DETERMINED THAT THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "NO ALARM." A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2010- 04849. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE THE GUIDE WIRE PERFORATED THE BALLOON CATHETER. THE 80% STENOSED LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED LEFT POSTERIOR TIBIAL ARTERY. THE PHYSICIAN ADVANCED THE .014 X 145CM PLATINUM PLUS GUIDE WIRE ACROSS THE LESION. NEXT, WHILE THE 3MM X 40MM X 145CM STERLING BALLOON CATHETER WAS ADVANCED THROUGH THE MID POPLITEAL ARTERY THE GUIDE WIRE PERFORATED THE "MID BALLOON" AREA OF THE STERLING. THE BALLOON WAS NEVER INFLATED. THE PHYSICIAN REMOVED BOTH DEVICES TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON AND A NON-BSC GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP THAT IS NOT ALARMING AT ALL. IT IS UNKNOWN WHEN OR AT WHAT POINT IN THE PROCESS THIS CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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