BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1943172 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07460
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    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
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(64) - ON A FOLLOW UP CALL TO THE HP ON (B)(6) 2011, THE DAUGHTER STATED THAT THE HP HAD A REOCCURRENCE OF PERITONITIS 2 WEEKS AFTER THE INITIAL EVENT AND WAS AGAIN HOSPITALIZED FOR 4-5 DAYS. THE HP HAD BEEN ADMITTED TO A REHAB CENTER AFTER THE INITIAL HOSPITALIZATION WHEN THE INCIDENT OCCURRED. THE DAUGHTER REPORTED TREATMENT STARTED IN THE HOSPITAL WITH VANCOMYCIN IP WEEKLY(DOSE UNKNOWN) AND HAD CONTINUED FOR "SEVERAL" WEEKS AFTER DISCHARGE. BAXTER CONTACTED THE PDRN ON (B)(6) 2011 WHO STATED THAT SHE HAD NO KNOWLEDGE OF THE INCIDENT REOCCURRING. CULTURE AND TEST RESULTS WERE NOT KNOWN, BUT SHE STATED THAT THE HP HAD FULLY RECOVERED PRIOR TO THE CLINIC APPOINTMENT ON (B)(6) 2010.

    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. AS FURTHER INFORMATION IS OBTAINED, A FOLLOW UP WILL BE SUBMITTED. THIS IS THE FIRST OF THREE COMPLAINTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H10H21064 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, BAXTER TECHNICAL SERVICES RECEIVED A CALL FROM THE HOME PATIENT'S(HP) MEDICAL ASSISTANT WITH A REPORT OF NEW ONSET ABDOMINAL PAIN AND EXTREME TENDERNESS, ANOREXIA FOR UNSPECIFIED DURATION, VOMITING AND DIFFICULTY WITH DRAIN DURING PERITONEAL DIALYSIS. ON (B)(4) 2010 PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HP'S NURSE WHO STATED THE HP WAS STILL IN THE HOSPITAL AND DOING WELL. ON (B)(4) 2010, PRODUCT SURVEILLANCE SPOKE WITH THE HP'S NEPHROLOGIST(MD): THE HP WAS HOSPITALIZED FOR 4 DAYS WITH BACTERIAL PERITONITIS, WAS CULTURED AND TREATED INTRAPERITONEALLY WITH VANCOMYCIN AND FORTAZ (DOSES AND DURATION NOT PROVIDED). THE HP FOLLOWED UP IN THE MD'S OFFICE (B)(6) 2010. THE MD STATED THAT THE HP IS FULLY RECOVERED. THE HP HAS RECEIVED DAILY TREATMENTS OF AUTOMATED PERITONEAL DIALYSIS WITH LOCAL PD4 AMBUFLEX FOR AN UNSPECIFIED DURATION, AND HAS CONTINUED WITH THE SAME SINCE THE EVENT. THE MD DID NOT GIVE A CAUSALITY STATEMENT, BUT STATED THAT THE "BAXTER PRODUCTS ARE GREAT" AND NOT SUSPECT IN THIS EVENT. CONCOMITANT MEDICATIONS WERE NOT DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R LOCAL PD4 AMBUFLEX