BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1871913 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04519
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 20, 2010
    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). THIS COMPLAINT FOR A DAMAGED MINICAP WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS THE FIRST OF 3 EMDRS BEING SUBMITTED FOR THIS PRODUCT REPORT. PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. 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 HOME PATIENT'S (HP)'S CAREGIVER (CG) CONTACTED BAXTER REPORTING THAT SHE DISCOVERED THREE CRACKED MINICAPS BEFORE USE. DURING A FOLLOW UP CALL, THE CG REPORTED THAT UPON CLEANING UP THE BETADINE (USING AN ALCOHOL SWAB) OFF THE MINICAP AFTER PLACING THE MINICAPS ON THE TRANSFER SET, SHE NOTICED THE CRACKS. THE OTHER 2 TIMES, THE CG NOTICED THE CRACKS AFTER PLACING THE MINICAPS ON THE TRANSFER SET. THE CG STATED THAT ALL 3 MINICAPS CAME OUT OF THE SAME BOX. THE CG STATED THAT THE LAST TIME THE TRANSFER SET WAS REPLACED IN (B)(6) 2010. THE CG STATED THAT SHE HAD NOT NOTICED ANY DEFECTS ON THE MINICAPS OR THE TRANSFER SETS WHILE PLACING THE MINICAPS ON. PER THE CG, SHE HAND TIGHTENS THE MINICAP, AND DOES NOT OVERTIGHTEN. PER THE CG, THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 14 YR