BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2268779 · Received September 29, 2011

    Report

    Report Number
    1423500-2011-12865
    Event Type
    Malfunction
    Date Received
    September 29, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - GUANGZHOU
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.THE SAMPLE LOT NUMBER IS KNOWN, THEREFORE A BATCH REVIEW WILL BE PERFORMED. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF DAMAGED MINICAP WAS CONFIRMED. IT HAS BEEN CONFIRMED THAT THIS DEFECT WAS CAUSED BY MINICAP SUPPLIER DURING THE MANUFACTURE PROCESS. A REVIEW OF FILE OF THE BATCH REPORTED REVEALED NO ANY EXCEPTION REGARDS THIS ISSUE FOUND IN THE MANUFACTURING PROCESS. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH GZP-(B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED TO BAXTER AN ISSUE OF HAIRLINE CRACK IN A MINICAP FOUND DURING USE.THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR INTERVENTION WAS REPORTED INITIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - GUANGZHOU GM1101004

    Patients

    Seq Age Sex Outcome Treatment
    1