BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2233924 · Received September 6, 2011

    Report

    Report Number
    1423500-2011-11698
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H11E06052, H11D16047 AND H11C25016 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. THE COMPLAINT WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. 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. 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 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 3 INVOLVED IN THIS PERITONITIS INCIDENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A HEALTH CARE PROFESSIONAL (HCP) WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(4) OF PERITONITIS, CLOSTRIDIUM DIFFICILE (C DIFF) INFECTION AND VOMITING IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED AS A RESULT OF THE PERITONITIS. TREATMENT INCLUDED IP FORTAZ AND IP ANCEF (DOSE, FREQUENCY AND START/STOP DATES NOT REPORTED). THE PERITONITIS WAS RESOLVED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED VOMITING. ON UNKNOWN DATES, THE PATIENT WAS DIAGNOSED WITH C. DIFF MANIFESTED BY DIARRHEA. TREATMENT INCLUDED FLAGYL (DOSE, ROUTE AND START/STOP DATES WERE NOT REPORTED). ON (B)(6) 2011, THE DIARRHEA WAS RESOLVED AND THE PATIENT WAS DISCHARGED AND TRANSFERRED TO A REHABILITATION FACILITY. THE OUTCOME OF THE VOMITING WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. THE HCP AND THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. THE NURSE REPORTED THAT THE DIARRHEA WAS NOT RELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY WAS NOT PROVIDED FOR THE EVENTS OF C. DIFF INFECTION AND VOMITING. A SEARCH OF (B)(4) FOR SUSPECT PRODUCTS SHIPPED WITHIN TWO MONTHS BEFORE THE INCIDENT SHOWED THE FOLLOWING: L5C4531, LOT NUMBERS H11E06052, H11D16047 AND H11C25016.

    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 76 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| HOMECHOICE