BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1981493 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01637
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 17, 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). A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. THE PRODUCT SAMPLE HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). FIFTY SEVEN (57) COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. A RANDOM SAMPLING OF THIRTY (30) WAS SELECTED AND TIGHTENED ON TRANSFER SET LURES FOR INSPECTION. THE REPORTED CONDITION OF A LEAK WAS NOT CONFIRMED IN THE LAB. THE RESULTS OF A BATCH REVIEW REVEALED NO DEFECTS DURING THE MANUFACTURING PROCESS. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) REPORTED TO PRODUCT SURVEILLANCE THAT SHE HAD NOTED AN UNSPECIFIED QUANTITY OF HER MINICAPS SEEMED TO BE FITTING A LITTLE LOOSER THAN USUAL; THEREFORE, SHE WAS NOT COMFORTABLE USING ANY MORE PRODUCT SHE CURRENTLY HAS AT HOME. THE HP STATED SHE IS VERY CAUTIOUS WITH HER TECHNIQUE AND ENSURES SHE KEEPS THE AREA STERILE. ON (B)(6) 2011 THE HP CALLED PRODUCT SURVEILLANCE TO REPORT SPECIFIC LOT INFORMATION; THE HP FURTHER STATED A NURSE TOLD HER TO USE TAPE FOR ANY LOOSE MINICAPS. THE HP ADVISED WHEN SHE SPOKE WITH HER PERITONEAL DIALYSIS (PD) NURSE (RN), SHE WAS ADVISED THAT SHE SHOULD CONTACT BAXTER REGARDING THE PRODUCT ISSUE. THE HP CONFIRMED NEW PRODUCT WAS RECEIVED AND SHE IS RESUMING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD874826

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR HOMECHOICE PRO APD SYSTEM (B)(4)