BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2962051 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03781
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EPISODE OF THE RECURRENT PERITONITIS OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2012. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 5 OF 11 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PERITONITIS IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED EVENT. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS H12D15014, H12E11093, H12F28038 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A NURSE OF A PATIENT WITH PERITONITIS. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS AND DISCHARGED AT A LATER DATE. THE PATIENT HAD JUST RECENTLY FINISHED THE LAST ROUND OF UNSPECIFIED ANTIBIOTICS FROM THE LAST EPISODE OF PERITONITIS AND THE PATIENT STILL HAD ISSUES WITH PERITONITIS RETURNING. FOLLOW UP INFORMATION WAS RECEIVED FROM A NURSE. THE NURSE REPORTED THAT THE PATIENT HAS EXPERIENCED MULTIPLE CASES OF RECURRENT PERITONITIS. THE CAUSATIVE AGENT FOR ALL EPISODES WAS (B)(6). FOR EVERY EPISODE OF RECURRENT PERITONITIS, THE PATIENT WAS TREATED WITH VANCOMYCIN AND GENTAMYCIN, INTRA-PERITONEALLY (DOSES AND FREQUENCIES UNKNOWN). THE NURSE STATED THAT AFTER RECOVERING FROM EACH EPISODE OF PERITONITIS, THE PATIENT WOULD GET PERITONITIS AGAIN WITHIN A FEW WEEKS OF THE PREVIOUS EPISODE. THE NURSE REPORTED THAT THE PATIENT WAS RE-CULTURED AFTER EACH EVENT OF PERITONITIS TO MAKE THE DETERMINATION THAT HE HAD RECOVERED FROM EACH EVENT. THE RESULTS OF THE CULTURES HAD SHOWN NO GROWTH. THE NURSE STATED THAT THE CAUSE OF THE RECURRENT PERITONITIS IS UNKNOWN. THE PATIENT DENIES ANY BREAK IN ASEPTIC TECHNIQUE BUT THE PATIENT WAS RETRAINED IN PROPER ASEPTIC TECHNIQUE AFTER EACH EPISODE OF RECURRENT PERITONITIS. THE PATIENT HAS RECOVERED FROM THIS EVENT OF PERITONITIS. PERITONEAL DIALYSIS THERAPY WAS ONGOING AND, PER THE NURSE, THE RECURRENT PERITONITIS IS NOT RELATED TO BAXTER?S DIANEAL SOLUTION, DEVICE, OR DISPOSABLE PARTS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. SAME PATIENT AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65760 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX (2.5%)