BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2070007 · Received April 26, 2011

    Report

    Report Number
    1423500-2011-05037
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 8, 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). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS USE ERROR, POOR ASEPTIC TECHNIQUE. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS (H11A04056, H10L22024) AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. 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 REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF THE PATIENT WHO MADE A MISTAKE/TOUCH CONTAMINATION, PAIN FROM DIVERTICULITIS, FEVER AND PERITONITIS WITH CULTURE POSITIVE FOR "LIGHT E COLI" COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING INFORMATION. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED PERITONITIS. THE NURSE REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE AND EXPERIENCED TOUCH CONTAMINATION, AND DEVELOPED PAIN FROM DIVERTICULITIS. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2011 THE PATIENT WAS TREATED WITH IP VANCOMYCIN AND IP GENTAMYCIN (DOSES AND FREQUENCIES NOT REPORTED). ON (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND A FEVER AND WAS HOSPITALIZED. WHILE HOSPITALIZED, THE PATIENT WAS TREATED WITH FORTAZ 500MG IP DAILY THAT WAS ONGOING. THE PATIENT WAS DIAGNOSED WITH DIVERTICULITIS DURING HOSPITALIZATION. DIANEAL THERAPY WAS ONGOING. ON (B)(6) 2011, THE PATIENT WAS RECOVERING FROM THE EVENTS AND WAS DISCHARGED. PER THE NURSE, THE FEVER WAS UNRELATED TO DIANEAL THERAPY. THE OUTCOME OF THE PATIENT MADE A MISTAKE AND TOUCH CONTAMINATION WAS NOT REPORTED. PER THE NURSE, THE PERITONITIS AND PAIN FROM DIVERTICULITIS WAS UNRELATED TO DIANEAL THERAPY. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION.

    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 69 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX