BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2220422 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11095
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H11D30014 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE COMPLAINT WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. 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.

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 1 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS AND CATHETER INFECTION IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON UNREPORTED DATES DURING 2011, THE PATIENT EXPERIENCED PERITONITIS FIVE TIMES WHILE UNDER THE CARE OF ANOTHER (B)(6) CLINIC. THE DATES OF ONSET AND OUTCOMES WERE UNABLE TO BE ASSESSED AS THE PATIENT WAS AT A DIFFERENT PD CLINIC AT THAT TIME. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY. WHILE HOSPITALIZED, THE PATIENT EXPERIENCED A CATHETER INFECTION. THE CAUSE OF THE CATHETER INFECTION WAS DUE TO THE PREVIOUS OCCURRENCES OF PERITONITIS. ON AN UNREPORTED DATE, TREATMENT INCLUDED REMOVING THE PD CATHETER, WITHDRAWING DIANEAL THERAPY, AND PLACING THE PATIENT ON HEMODIALYSIS. OTHER TREATMENT DURING HOSPITALIZATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL IN THE HOSPITAL, HAD NOT RECOVERED, AND REMAINED ON HEMODIALYSIS. THE OUTCOME OF THE EVENT OF CATHETER INFECTION WAS NOT REPORTED. THE NURSE REPORTED THAT SHE COULD NOT ASSESS THE PREVIOUS EVENTS OF PERITONITIS. THE NURSE REPORTED THAT THE (B)(6) 2011 PERITONITIS EVENT AND CATHETER INFECTION WERE UNRELATED TO DIANEAL THERAPY.

    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 51 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 ULTRABAG