BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2061103 · Received April 18, 2011

    Report

    Report Number
    1423500-2011-04629
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 27, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER, THEREFORE THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED BY BAXTER ON (B)(6) 2011: THE PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT THE PATIENT WAS GETTING BACTERIAL PERITONITIS. SHE ALLEGED THAT THE PERITONITIS WAS RELATED TO A "SYSTEM ERROR" ALARM ON THE MACHINE AND THAT IT HAD SOMETHING TO DO WITH GETTING AIR IN THE LINE. THE NURSE REPORTED THAT ON (B)(6) 2011 PD EFFLUENT CULTURE AND CELL COUNT WERE TAKEN AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON AN UNKNOWN DATE THE PATIENT WAS TREATED WITH TAZICEF. ON AN UNKNOWN DATE, AFTER THE CULTURE RESULTS WERE RECEIVED THE PATIENT WAS STARTED ON VANCOMYCIN 1GM, EVERY 5 DAYS FOR AN UNSPECIFIED AMOUNT OF TIME. THE NURSE REPORTED THAT A SYSTEM ERROR ON THE MACHINE (WHICH HAD SOMETHING TO DO WITH GETTING AIR IN THE LINE) COULD HAVE CAUSED THE PERITONITIS. ON (B)(6) 2011, BAXTER CONTACTED THE PD NURSE WHO REPORTED THE PERITONITIS WAS ONGOING BUT HAD NO FURTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE SYSTEM ERROR 2240 ALARM WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE, WHICH OCCURRED DURING CYCLE 3 OF 6. A SE 2240 IS A NON-RECOVERABLE ALARM THAT OCCURS WHEN THE DEVICE HAS DETECTED AIR BEING DRAWN CONTINUOUSLY INTO THE DISPOSABLE. IT IS UNKNOWN IF THIS ALARM OCCURRED DURING PATIENT THERAPY, HOWEVER NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 77 YR Required Intervention HOMECHOICE| DIANEAL LOCAL (PD4) AMBUFLEX