BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1745533 · Received July 2, 2010

    Report

    Report Number
    6000001-2010-00804
    Event Type
    Malfunction
    Date Received
    July 2, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 8, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF FAILURE CODE 810:11 AND DETERMINED THE ROOT CAUSE TO BE AN OUT OF CALIBRATION AIR IN LINE PRINTED CIRCUIT BOARD. THE AIR IN LINE PRINTED CIRCUIT BOARD WAS RE-CALIBRATED TO REPAIR THIS CONDITION. THE DEVICE MET SPECIFICATION FOR THE REPORTED CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH MULTIPLE 810:11 FAILURE CODES IN THE HISTORY. IT IS UNKNOWN WHEN OR AT WHAT POINT IN THE PROCESS THIS EVENT OCCURRED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS (B)(4), WHICH IS CLASSIFIED AS COLLEAGUE 2006. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE AMERICAN HEART JOURNAL 2010; 160:775.E1-775.E9 ARTICLE ENTITLED "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION" THAT A PATIENT EXPERIENCED STENT FRACTURE AND SEPARATION AND RESTENOSIS. (B)(6). THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS IN THE CIRCUMFLEX ARTERY, BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS AN IN-STENT RESTENOSIS, BUT WAS NOT A CHRONIC TOTAL OCCLUSION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, A 3.0 X 23MM CYPHER BX WAS IMPLANTED. THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP ANGIOGRAM (6 TO 9MONTHS AFTER THE IMPLANT), THE STENT FRACTURE AND 90% FOCAL RESTENOSIS WERE OBSERVED. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RESTENOSIS WAS LOCATED IN FRACTURE SITE. POPMA ET AL CLASSIFICATION WAS III (COMPLETE SEPARATION WITHOUT DISPLACEMENT).

    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