BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2230381 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11514
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 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). SIX UNOPENED SAMPLES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLES REVEALED THE PRESENCE OF IODINE IN ALL SIX MINICAPS. A LEAK TEST WAS PERFORMED UNDERWATER ON THE POUCHES WHICH REVEALED NO LEAKS. THIS COMPLAINT FOR INADEQUATE IODINE WAS NOT CONFIRMED. 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 COMPLAINT DATA TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE IS AVAILABLE FOR EVALUATION. AN EVALUATION WILL BE PERFORMED ON THE PROVIDED LOT NUMBER. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A HOMECARE SERVICE REPRESENTATIVE (HCSR) RELAYED A REPORT FROM A HOME PATIENT (HP) WHO HAD FOUND AN UNKNOWN QUANTITY OF DISCONNECT CAPS THAT WERE DRY OF ANY IODINE. THE HOME PATIENT (HP) CONTACTED THIS WRITER ON (B)(6) 2011. THE HP STATED THE DISCONNECT CAP WAS DRIED OUT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 GD885285

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR