BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1875316 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04642
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE (PS) SPOKE WITH HOME PATIENT (HP) ON 30 NOV 2010, WHO ADVISED THAT HE DID NOT DEVELOP ANY ADVERSE CLINICAL SYMPTOM OR EFFECT FROM THIS INCIDENT. THE HP STATED THAT THE SAMPLE WAS DISCARDED. NO LOT NUMBER OR FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE INCIDENT WAS UNDETERMINED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. 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

    AT A (B)(6)) MEETING, THE PATIENT (NOW HAS A TRANSPLANT) REPORTED THAT THE MINI-CAP HAD FALLEN OFF ONCE WHILE HE WAS AT WORK. HE DISCOVERED THE CAP WAS OFF WHEN HE FELT A ROUGH SURFACE INSTEAD OF THE SMOOTH MINI-CAP FROM UNDER HIS SHIRT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR