BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2964044 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03959
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS UNDETERMINED. THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR LOT NUMBER GD891101, GD892646 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. WHILE PERFORMING A BATCH REVIEW ON BATCH GD893313, IT WAS DETERMINED THAT A NONCONFORMANCE (IR-12-0040) OCCURED ON THE BATCH FOR A WEAK SEAL. ALL AFFECTED MATERIAL WAS REMOVED FROM BATCH GR893313, AND THE BATCH WAS RELEASED. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AN EVALUATION OF THE COMPANION SAMPLES WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE EVALUATION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE ACTUAL SAMPLE HAS BEEN MADE. SHOULD THE ACTUAL SAMPLE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CONNECTION ISSUE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE CALLER SAID HIS MINICAP CAME OFF LAST NIGHT AND HE WAS TOLD BY HIS REGISTERED NURSE (RN) NOT TO DO THERAPY THAT NIGHT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S NURSE AND SHE SAID THAT SHE WAS NOT THE NURSE WHO SPOKE TO THE PATIENT BUT SHE WAS AWARE OF THE PATIENT HAVING HAD THAT ISSUE. SHE SAID SHE WAS NOT SURE IF THERE WAS AN ISSUE WITH THE SUPPLIES OR IF THE PATIENT HAD NOT PUT THE MINICAP ON CORRECTLY BUT SHE SAID HIS TRANSFER SET WAS REPLACED. SINCE THEN THE PATIENT HAS BEEN COMPLETING THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. PRODUCT SURVEILLANCE RECEIVED A CALL FROM THE HOME PATIENT AT A LATER DATE AND HE SAID THAT HE WAS NOT SURE WHY THE MINICAP FELL OFF. HE DID NOT NOTICE ANYTHING WRONG WITH THE MINICAP OR TRANSFER SET. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69227 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOME CHOICE