BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2240564 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11919
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR- POOR ASEPTIC TECHNIQUE. A BATCH REVIEW OF THE POTENTIALLY ASSOCIATED LOT NUMBERS (H11C07014, H11C19019, H11B05010) REVEALED NO EXCEPTIONS DURING THE MANUFACTURING PROCESS. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE AND IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF BREAK IN ASEPTIC TECHNIQUE AND BACTERIAL PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN THERAPY WITH DIANEAL PD4 AMBUFLEX (2.8L, FREQUENCY NOT REPORTED) AND EXTRANEAL VIAFLEX (2.3L, FREQUENCY NOT REPORTED), INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). DURING A FOLLOW UP CALL BY BAXTER REPRESENTATIVE, THE PATIENT'S NURSE REPORTED THE FOLLOWING: ON AN UNREPORTED DATE IN 2011 A BREAK IN ASEPTIC TECHNIQUE OCCURRED FURTHER DESCRIBED AS THE PATIENT DISCONNECTED, CAPPED OFF HIS TRANSFER SET, BUT DID NOT CAP OFF THE TUBING COMING FROM THE HOMECHOICE MACHINE. ON (B)(6) 2011 THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6). INTERMEDIUS. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT RECEIVED REMEDIAL THERAPY WITH VANCOMYCIN (IP, DOSE AND FREQUENCY NOT REPORTED) AND VANCOMYCIN (IV, DOSE AND FREQUENCY NOT REPORTED). DURING THE HOSPITAL STAY, THE PATIENT'S PERITONEAL DIALYSIS (PD) CATHETER MIGRATED OUT OF POSITION FOR UNKNOWN REASON AND WOULD NOT DRAIN. THE PATIENT WAS TEMPORARILY PUT ON BACK-UP HEMODIALYSIS. ON (B)(6) 2011 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2011, REMEDIAL THERAPY WITH VANCOMYCIN WAS DISCONTINUED. THE OUTCOME FOR THE EVENT OF BACTERIAL PERITONITIS WAS REPORTED AS ONGOING AND IMPROVED. THE PATIENT RECEIVED RETRAINING ON ASEPTIC TECHNIQUE; THEREFORE, THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS CONSIDERED RESOLVED. DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES WERE ONGOING. THE NURSE BELIEVED THE EVENT OF BACTERIAL PERITONITIS WAS NOT RELATED TO PD THERAPY. THE NURSE DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R EXTRANEAL VIAFLEX| DIANEAL PD4 AMBUFLEX