BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2061592 · Received April 18, 2011

    Report

    Report Number
    1423500-2011-04656
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    August 1, 2010
    Report Date
    March 23, 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 3 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). A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOTS H11A15508, H10L15135 WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL FOR AN UNRELATED COMPLAINT ON 23 MAR 2011, THE HOME PATIENT (HP) MENTIONED THAT HE HAS HAD AN E. COLI INFECTION FOR THE LAST FEW MONTHS AND HAD BEEN ADDING ANTIBIOTICS TO HIS THERAPY. ON 24MAR2011, THE HP'S NURSE WAS CONTACTED, AND SHE STATED THAT THE HP HAD RELAPSING PERITONITIS. BAXTER CONTACTED THE PERITONEAL DIALYSIS RN ON 5 APRIL 2011 TO OBTAIN ADDITIONAL INFORMATION ON THIS REPORT OF PERITONITIS. SHE REPORTED THE PATIENT HAS HAD RECURRING PERITONITIS SINCE (B)(6) 2010. AT THAT TIME PD CULTURES WERE DONE ON NUMEROUS OCCASIONS AND THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS. SHE REPORTED THAT IN (B)(6) 2011, THE DOCTOR ORDERED THE PATIENT BE TREATED WITH 6 WEEKS OF ORAL AND INTRA-PERITONEAL ANTIBIOTICS. THE PATIENT WAS ORDERED LEVAQUIN (UNKNOWN DOSE) BY MOUTH AND FORTAZ (UNKNOWN DOSE) IP. THE PATIENT IS BEING TREATED PROPHYLACTICALLY WITH GENTAMICIN AT THE EXIT SITE, BUT DOES NOT HAVE AN EXIT SITE INFECTION. SHE REPORTED THE PATIENT'S PD EFFLUENT IS CLEAR AND HE HAS NO SYMPTOMS AT THIS TIME. THE PD CATHETER WILL BE PULLED THIS WEEK AND THE PATIENT WILL BE PLACED ON TEMPORARY HEMODIALYSIS UNTIL THE PERITONITIS HAS RESOLVED. THERE WAS NO ALLEGATION AGAINST ANY BAXTER PRODUCT OR SOLUTION. THE RN HAD NO OPINION OF CAUSALITY. THERE WAS NO FURTHER INFORMATION 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 70 YR Required Intervention DIANEAL LOCAL (PD4) AMBUFLEX| HOME CHOICE CYCLER