BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1912535 · Received December 2, 2010

    Report

    Report Number
    6000001-2010-05364
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11 WAS CONFIRMED IN THE PUMP'S EVENT HISTORY BY A BAXTER SERVICE TECHNICIAN. THIS CONDITION WAS CAUSED BY THE PUMP'S AIR IN LINE PRINTED CIRCUIT BOARD BEING OUT OF CALIBRATION. THE AIR IN LINE PRINTED CIRCUIT BOARD WAS CALIBRATED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW OF THE EVENT HISTORY, THE OCCURRENCE DATE OF THIS EVENT WAS DETERMINED TO BE (B)(6) 2010. THIS DATE WAS ERRONEOUSLY OMITTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON REVIEW, THE CORRECT AWARE DATE OF THIS REPORT IS (B)(6) 2010, NOT THE ORIGINALLY REPORTED DATE OF (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. 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.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH FAILURE CODE 810:11, WHICH OCCURRED ON CHANNEL A. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. UPON REVIEWING THE PUMP'S EVENT HISTORY, BAXTER QUALITY ENGINEERING DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90.

    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