BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1981771 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01646
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 16, 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). 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 FOR LOOSE CONNECTION. ZERO OF THE THIRTY (0/30) WAS CONFIRMED FOR LOOSE CONNECTION. THIS REPORT 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.

    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.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) REPORTED TO PRODUCT SURVEILLANCE THAT HER MINICAP HAD FALLEN OFF HER TRANSFER SET THE NIGHT BEFORE. THE HP STATED HER TRANSFER SET WAS REPLACED AT THE HOSPITAL AND A MINICAP FROM THE HOSPITAL SUPPLY WAS USED. THE HP STATED SHE IS VERY CAUTIOUS WITH HER TECHNIQUE AND ENSURES SHE KEEPS THE AREA STERILE. THE HP FURTHER ADVISED THAT ON THE (B)(6) JANUARY, WHEN SHE NOTED THE CAP HAD FALLEN OFF, SHE CALLED HER DOCTOR'S OFFICE FOR ADVICE. THE HP STATED A NURSE TOLD HER TO CONTINUE HER THERAPY THAT EVENING AND 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 NOT HAVE CONDUCTED THERAPY AND TO CONTACT BAXTER REGARDING THE PRODUCT ISSUE. THE HP STATED SHE NOW KNOWS TO CONTACT HER PDRN FOR ANY PROBLEMS.

    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 GD878843

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR