BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2132127 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07743
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    October 1, 2010
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PD CATHETER WAS REMOVED IN (B)(6) 2011 DUE TO THE RECURRENT ORGANISM THAT CAUSED THE PERITONITIS. THE HP WOULD CONTINUE WITH HD UNTIL (B)(6) 2011 WHEN SHE WOULD HAVE ANOTHER PD CATHETER PLACED AND RESUME PD THERAPY. THE 3 DAY CULTURES OBTAINED IN (B)(6) 2010 WERE ALL POSITIVE FOR (B)(6). INITIAL TREATMENT WAS NOT REPORTED. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS H09A15064 AND H10F01037 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. WITHOUT A SAMPLE OR FURTHER INFORMATION REGARDING THE CIRCUMSTANCES ASSOCIATED WITH THE EVENT, THE ROOT CAUSE FOR THE POSSIBLE SEPARATION AND PERITONITIS IS UNDETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4) - AS THE DATE OF ONSET OF THIS PERITONITIS EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A BAXTER CLINICAL EDUCATOR REPORTED THAT A DIALYSIS UNIT NURSE REPORTED A TRANSFER SET HAD BECOME DISCONNECTED ON A HOME PATIENT (HP) OCCURRING IN (B)(6) 2010. THE HP DEVELOPED MULTIPLE EPISODES OF PERITONITIS DUE TO THE EVENT. ON (B)(6) 2011, THE PERITONEAL DIALYSIS NURSE (PDRN) CONTACTED BAXTER REGARDING THE EVENT. THE HP WAS EATING AT THE TIME AND BECAME AWARE OF THE DISCONNECTION WHEN SHE FELT WET. THE PDRN STATED THAT THE TRANSFER SET WAS REPLACED AFTER THE INCIDENT. THE PDRN REPORTED THAT THE HP DEVELOPED SEVERAL EVENTS OF INFECTION AFTER THE EVENT, AND WAS RECEIVING HEMODIALYSIS(HD) AT THE TIME OF THE REPORT. THE PDRN OR THE HP COULD NOT GIVE CAUSALITY FOR THE DISCONNECTION. ON (B)(6) 2011, BAXTER SPOKE WITH THE PDRN WHO STATED THAT THE HP'S PERITONEAL DIALYSIS(PD) CATHETER WAS REMOVED IN (B)(6) 2011 DUE TO THE RECURRENT ORGANISM CAUSING THE PERITONITIS. THE HP WOULD CONTINUE WITH HD UNTIL (B)(6) 2011 WHEN SHE WOULD HAVE A NEW PD CATHETER PLACED AND RESUME PD THERAPY. ON (B)(6) 2011, BAXTER CONTACTED THE PDRN FOR PD CELL COUNTS AND CULTURE RESULTS. ONGOING TREATMENT WAS NOT REPORTED, BUT ON (B)(6) 2011, VANCOMYCIN 2GM INTRAPERITONEALLY (IP) FOR 5 DOSES WAS INITIATED WITH GENTAMICIN 160MG IP DAILY FOR 2 WEEKS. ON (B)(6) 2011, BACTRIMDS BY MOUTH TWICE DAILY WAS GIVEN UNTIL THE PD CATHETER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R HOMECHOICE| LOCAL(PD4)ULTRABAG| LOCAL(PD4)AMBUFLEX