BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2062862 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04696
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 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): THIS IS REPORT 1 OF 4 FOR THIS INCIDENCE OF PERITONITIS. AS PATIENT DISCARDS SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE POTENTIALLY ASSOCIATED LOTS FOR THIS COMPLAINT ARE ( H10L15085, H10L07058). A BATCH REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS

    Description of Event or Problem · 1

    DURING A PHONE CALL FOR AN UNRELATED ALARM THE PATIENT REPORTED THAT HE HAD PERITONITIS. HE STATED THE FLUID IN THE TUBING WAS "THICK AND CLOUDY LIKE SOAP". NO FURTHER INFORMATION WAS AVAILABLE. BAXTER CONTACTED THE PERITONEAL DIALYSIS (PD) RN ON (B)(6) 2011, TO FOLLOW UP ON THE REPORTED PERITONITIS COINCIDENT WITH DIANEAL LOCAL (PD4) AMBUFLEX. THE NURSE CONFIRMED THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2011, THE PATIENT WENT TO THE ER WITH ABDOMINAL PAIN. THE PATIENT WAS TREATED WITH VANCOMYCIN (UNKNOWN DOSE) IP. THERE WAS NO EXIT SITE INFECTION. SHE REPORTED THE POSSIBLE CAUSE OF THIS INCIDENT OF PERITONITIS WAS BECAUSE THE PATIENT WAS CONSTIPATED. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. THERE WAS NO ALLEGATION AGAINST ANY BAXTER DEVICE OR SOLUTION. THE PERITONITIS RESOLVED. THE PATIENT CONTINUES PD THERAPY WITHOUT INCIDENT. NO FURTHER INFORMATION WAS AVAILABLE.

    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 Required Intervention DIANEAL LOW CAL (PD4) AMBUFLEX| HOMECHOICE