BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2069075 · Received April 25, 2011

    Report

    Report Number
    1423500-2011-04976
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOTS (H10J08118 AND H10I11055) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THOSE LOTS. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF EXTREME LEG PAIN, GI BLEED, NOSOCOMIAL SOURCE, AND PERITONITIS IN AN APPROXIMATELY (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED EXTREME LEG PAIN AND INTERNAL BLEEDING AND WAS HOSPITALIZED ON THE SAME DAY. UPON A FOLLOW-UP CALL, THE NURSE REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED A GI BLEED AND WAS HOSPITALIZED THE SAME DAY. TREATMENT FOR THE GI BLEED WAS NOT REPORTED. WHILE HOSPITALIZED, ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. IT WAS NOT REPORTED IF A PERITONEAL EFFLUENT CULTURE WAS PERFORMED. THE CAUSE AND OUTCOME OF THE PERITONITIS WERE NOT REPORTED. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENTS OF EXTREME LEG PAIN, INTERNAL BLEEDING AND GI BLEED. DIANEAL THERAPY WAS ONGOING. THE NURSE REPORTED THAT THE GI BLEED WAS UNRELATED TO DIANEAL THERAPY. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE PERITONITIS OR THE EVENTS OF EXTREME LEG PAIN AND INTERNAL BLEEDING REPORTED BY THE CONSUMER. FURTHER INFORMATION WAS RECEIVED FROM THE PERITONEAL DIALYSIS (PD) NURSE ON (B)(6) 2011. ADVERSE EVENT INFORMATION AND CAUSALITY WERE ADDED OR REVISED. THE NURSE CLARIFIED THAT ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED AND HOSPITALIZED ON THE SAME DAY DUE TO GI BLEED AND NOT INTERNAL BLEEDING AS PREVIOUSLY REPORTED BY THE CONSUMER. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT EXPERIENCED AN EXPOSURE TO A NOSOCOMIAL SOURCE. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS RELATED TO A NOSOCOMIAL SOURCE. TREATMENT DURING HOSPITALIZATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. THE OUTCOME OF THE EVENT NOSOCOMIAL SOURCE WAS NOT REPORTED. THE NURSE REPORTED THAT THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPIES AND DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF NOSOCOMIAL SOURCE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    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 71 YR Hospitalization HOMECHOICE CYCLER| DIANEAL PD4 ULTRABAG| DIANEAL PD4 AMBUFLEX