BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2132110 · Received June 16, 2011

    Report

    Report Number
    1423500-2011-07739
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED BECAUSE, THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS REPORT ADDRESSES PRODUCT QUANTITY 18 OF 20.

    Description of Event or Problem · 1

    A BAXTER HOMECARE SERVICES REPRESENTATIVE (HCSR) CONTACTED (B)(4) VIA EMAIL TO RELAY REPORT RECEIVED FROM THE HOME PATIENT (HP) FOR MINICAP IN WHICH THE CAPS WERE NOTED TO BE DRIED OUT DURING SETUP ON UNKNOWN DATE(S). ON (B)(6), 2011 (B)(4) SPOKE WITH THE HP WHO STATED THAT THE SPONGE WAS WHITE AND APPEARED NOT TO HAVE ANY POVIDONE IODINE PRESENT. SHE STATED THERAPY IS GOING WELL AND REPORTED NO INJURY OR MEDICAL INTERVENTION.

    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 - CLEVELAND GD882621

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR