BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2173569 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09344
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 28, 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 NUMBER H11C18037 WITH NO ISSUES OR EXCEPTIONS NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER H11D26129 AND AN EXCEPTION WAS NOTED WITH NO INDICATION THE ISSUE IS RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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 REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 4 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 LOWER ABDOMINAL PAIN AND PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LOWER ABDOMINAL PAIN. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED AND WAS BEING RULED OUT FOR PERITONITIS. FURTHER INFORMATION WAS RECEIVED FROM THE PD CLINIC SECRETARY AND THE PD NURSE WHO REPORTED ON (B)(6) 2011, THE PATIENT EXPERIENCED LOWER ABDOMINAL PAIN AND WAS HOSPITALIZED ON THE SAME DAY. ON AN UNKNOWN DATE IN 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH UNSPECIFIED IP ANTIBIOTICS (STOP DATE, FREQUENCY, AND DOSE NOT REPORTED). ON AN UNKNOWN DATE IN (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAD RECOVERED. DIANEAL THERAPY WAS ONGOING. THE HEALTHCARE PROFESSIONAL REPORTED THAT THE LOWER ABDOMINAL PAIN WAS 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 18 YR Hospitalization| R DIANEAL PD2 AMBUFLEX| HOMECHOICE