BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1831526 · Received September 10, 2010

    Report

    Report Number
    6000001-2010-03145
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    June 10, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER REVIEW OF THE EVENT HISTORY DETERMINED THAT THE REPORTED CONDITION DID NOT INTERRUPT DEVICE DELIVERY. THIS CONDITION HAS BEEN DETERMINED TO BE NON-REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, HOWEVER DEVICE EVALUATION WAS PERFORMED ON-SITE BY A BAXTER FIELD SERVICE ENGINEER. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION DISCOVERED AND CONFIRMED THE REPORTED CONDITION OF A BATTERY DEPLETED ALARM, AND DETERMINED THE ROOT CAUSE TO BE DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESSES WERE REPLACED TO REPAIR THE REPORTED CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A DEPLETED BATTERY ALARM WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.92, WHICH IS CLASSIFIED AS REMEDIATED. NO ADDITIONAL INFORMATION IS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1