BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APO SET W/CASSETTE3-PRONG

    MDR report key: 1063155 · Received June 20, 2008

    Report

    Report Number
    1423500-2008-00521
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    April 21, 2008
    Report Date
    June 3, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOME PATIENT DISCARDED THE SAMPLES; THEREFORE, NO SAMPLE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP CALL FOR AN ADDITIONAL COMPLAINT, THE HOME PATIENT (HP) REPORTED HE DEVELOPED PERITONITIS IN 2008. THE HP WOKE UP IN THE MORNING AND WHEN TAKING THE CASSETTE OUT OF THE HOMECHOICE MACHINE AT END OF THERAPY. THE HP FELT MOISTURE ON THE CASSETTE. NO ALARMS WERE RECEIVED. THE HP DID NOT SEE ANY CUTS/SLICES/HOLES. THE SAMPLE WAS DISCARDED. LOT NUMBER IS UNKNOWN. THE HP USED SCISSORS TO OPEN THE BOX OF CASSETTES BUT STATED, HE DID NOT CAUSE DAMAGE TO THE CASSETTES. TECHNICAL SERVICES WAS NOT CONTACTED. ON THE FOLLOWING MONTH, PRODUCT SURVEILLANCE MADE A FOLLOW-UP CALL TO THE HP. THE HP STATED THAT AT SOMETIME IN LATE APRIL/EARLY MAY, THE HP FELT MOISTURE ON A DIFFERENT CASSETTE AT END OF THERAPY. THE HP STATED HE DEVELOPED PERITONITIS AFTER FINDING MOISTURE ON THE CASSETTE. ON THE SAME DAY, THE HP'S NURSE WAS CONTACTED AND STATED THE HP WAS DIAGNOSED WITH PERITONITIS ON A MONTH AND HALF BEFORE, BUT WAS NOT HOSPITALIZED. THE HP'S MEDICAL HISTORY INCLUDES DIABETES AND HYPERTENSION. THE HP IS ALLERGIC TO CODEINE. THE HP'S SYMPTOMS WERE ABDOMINAL PAIN AND A CLOUDY EFFLUENT. THE HP HAD A CELL COUNT, DIFFERENTIAL AND CULTURE PERFORMED ON THE SAME DAY, WITH RESULTS OF 157 WBCS, 19 RBCS, 91% NEUTROPHILS, 2% LYMPHOCYTES, 7% MONOCYTES AND A GROWTH OF HAEMOPHILUS PARAINFLUENZAE. THE HP WAS TREATED WITH VANCOMYCIN, 1 GRAM IP AND GENTAMYCIN, 40MG IP ON THE SAME DAY. THE HP WAS ALSO TREATED WITH LEVAQUIN 500MG LOADING DOSE, THEN 250MG ORAL EVERY 48 HOURS FROM THAT DAY TO CURRENT. THE HP WAS ALSO TREATED WITH ANCEF, 1.5 GRAMS, IP DAILY THREE DAYS LATER TO THE FOLLOWING MONTH. PER THE NURSE, THE HP HAS RECOVERED FROM THIS PERITONITIS EVENT, ALTHOUGH THE NURSE COULD NOT GIVE A DATE OF RECOVERY AND THE HP WAS STILL ON ANTIBIOTICS. WHEN ASKED FOR A SUSPECTED ROOT CAUSE OF THE PERITONITIS, THE NURSE STATED SHE DID NOT KNOW. WHEN ASKED ABOUT THE MOISTURE THE HP REPORTED ON HIS CASSETTE AT END OF THERAPY AS A POSSIBLE CAUSE OF THE PERITONITIS, THE NURSE STATED THAT SINCE SHE DID NOT SEE THE CASSETTE OR OBSERVE THE HP DOING THE THERAPY, SHE COULD NOT CONFIRM THE CASSETTE TO BE A CAUSE OF THE PERITONITIS. THE NURSE DID STATE, HOWEVER, THAT THE HP IS VERY METICULOUS REGARDING HD THERAPY, AND THE HP'S NEPHROLOGIST'S STATED THE HP WAS ONE OF HIS BEST PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APO SET W/CASSETTE3-PRONG 78FKX FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1