BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2213163 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10765
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS: H11C23052, H11B15068, AND H11A24039 WITH NO DEFECTS NOTED DURING THE MANUFACTURE OF THESE LOTS RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS NURSE REPORT FROM THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE PSEUDOMONAS AND HEARING ISSUES IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN, DIANEAL PD4 AMBUFLEX, AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). THE NURSE REPORTED THAT THE PERITONITIS WAS UNRELATED TO DIANEAL AND EXTRANEAL THERAPIES. THE EVENT OF PERITONITIS WAS AMENDED TO PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE PSEUDOMONAS. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON AN UNREPORTED DATE IN (B)(6) 2011, TREATMENT FOR THE PERITONITIS INCLUDED GENTAMICIN (DOSE, FREQUENCY, AND ROUTE NOT REPORTED). ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT EXPERIENCED UNSPECIFIED HEARING ISSUES THAT WERE RELATED TO THE GENTAMICIN. ON AN UNREPORTED DATE IN (B)(6) 2011, GENTAMICIN WAS DISCONTINUED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED DUE TO THE HEARING ISSUES. ON AN UNREPORTED DATE IN (B)(6) 2011, VANCOMYCIN WAS INITIATED (DOSE, FREQUENCY, AND ROUTE NOT REPORTED) TO TREAT THE PERITONITIS. UPON THE CULTURE RESULTS, VANCOMYCIN WAS DISCONTINUED. ON AN UNREPORTED DATE IN 2011, CIPRO AND FORTAZ WERE INITIATED (DOSES, FREQUENCIES, AND ROUTES NOT REPORTED) TO TREAT THE PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE PSEUDOMONAS. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE PSEUDOMONAS NOT IMPROVING. DURING HOSPITALIZATION ON AN UNREPORTED DATE IN (B)(6) 2011, TREATMENT INCLUDED REMOVAL OF PD CATHETER, WITHDRAWING PD THERAPY, AND STARTING THE PATIENT ON HEMODIALYSIS (HD). ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING AND REMAINED ON BACK-UP HD. IT WAS UNKNOWN IF THE PATIENT WOULD BE RETURNING TO PD. THE NURSE REPORTED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE PSEUDOMONAS AND HEARING ISSUES WERE UNRELATED TO DIANEAL AND EXTRANEAL THERAPIES.

    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 61 YR Hospitalization| R DIANEAL UNKNOWN| HOMECHOICE| EXTRANEAL VIALFLEX| DIANEAL PD4 AMBUFLEX