BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP

    MDR report key: 2011848 · Received March 9, 2011

    Report

    Report Number
    1423500-2011-02928
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 21, 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). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT. THIS REPORT IS 58 OF 60.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE AVAILABLE FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND NO FURTHER INFORMATION IS AVAILABLE, NO ROOT CAUSE CAN BE DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE 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

    BAXTER RENAL HOMECARE SERVICES REPRESENTATIVE (HCSR) LEFT A VOICE MESSAGE FOR CORPORATE PRODUCT SURVEILLANCE (CPS) TO RELAY A REPORT RECEIVED ON THE SAME DAY FROM THE HOME PATIENT (HP) IN WHICH "THE THREADS ARE NOT TIGHT; THE OTHER DAY ONE FELL OFF." THERE WAS PATIENT INVOLVEMENT. NO INJURY OR ADVERSE EVENT IS REPORTED. PRODUCT SURVEILLANCE WAS CONTACTED BY THE HP. THE HP STATED THE MINICAP'S WERE LOOSE DURING CONNECTION AND ONE EVENTUALLY FELL OFF. THE HP STATED THE NURSE WAS CONTACTED WHEN THE CAP FELL OFF THEN TRANSFER SET WAS REPLACED AND THE CAPS STILL WOULD NOT WORK WITH THAT TRANSFER SET. THE HP WAS PROVIDED WITH A NEW LOT OF MINICAPS AND THEY WERE WORKING PROPERLY. THE PATIENT HAD BEEN PERFORMING THERAPY FINE WITH THE NEW BOX OF CAPS AND NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD878843

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR MINICAP TRANSFER SET