BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1875277 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04638
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDJ
    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 EMDR ADDRESSES THE THIRD OF THREE SEPARATIONS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED. 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

    A CUSTOMER CONTACTED BAXTER REPORTING THAT THE MINI CAP HAD COME OFF ABOUT 4-5 MONTHS AGO; AND A 2ND TIME A COUPLE WEEKS AFTER THAT. DURING A FOLLOW UP WITH THE HOME PATIENT (HP) REGARDING THE MINICAPS FALLING APART, THE HP STATED THAT SHE DID NOT REMEMBER THE DATES OR MONTHS WHEN THE MINICAPS FELL APART, HOWEVER, THE HP STATED THAT IT ACTUALLY HAPPENED A TOTAL OF THREE TIMES THUS FAR. THE LAST TIME WAS ONLY A COUPLE OF WEEKS AGO ((B)(6) 2010). THE HP STATED THAT ALL THREE TIMES, SHE WAS ASLEEP AND WOKE-UP TO FIND THE MINICAP SEPARATED FROM THE TRANSFER SET AND THEN SHE WOULD REPLACE IT WITH A NEW MINICAP IMMEDIATELY. PER HP, THE FIRST TIME AROUND, HER NURSE GAVE HER PROPHYLACTIC ANTIBIOTICS AND SHE RESUMED THERAPY USING THE SAME TRANSFER SET. THE SECOND TIME THE MINICAP SEPARATED, HP'S NURSE DID NOT GIVE HER ANTIBIOTICS, BUT DID REPLACE HER TRANSFER SET. FINALLY, THE THIRD TIME WHEN THE MINICAP SEPARATED, HP'S NURSE ONCE AGAIN REPLACED THE TRANSFER SET, AND NO ANTIBIOTICS WERE GIVEN. PER HP, SHE HAD NO INJURY OR HARM AS A RESULT OF THESE INCIDENTS. THE HP ALSO STATED THAT SHE THOUGHT THAT THE MINICAPS CAME OUT OF DIFFERENT CASES. PER HP, SHE DID NOT NOTICE ANY DEFECTS ON THE TRANSFER SETS OR THE MINICAPS. THE HP WOULD PLACE THE MINCAPS IN THE DAY, AND THEY CAME OFF OVERNIGHT. PER HP, SHE HAS HAD NO OTHER PROBLEMS WITH THE MINICAPS. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR