BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1790309 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02316
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 17, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS: H10D10025 AND H10E19015 WITH NO DEVIATIONS FROM STANDARD PROCEDURE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS THE FIRST OF TWO COMPLAINTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    BECAUSE OF A GEAR PUMP MALFUNCTION ON THE 2P ROCHE MODULAR AUTOMATION LINE, HUNDREDS OF CREATININE RESULTS WERE FALSELY ELEVATED. THIS MALFUNCTION WAS NOT CONSTANT BUT SUFFICIENT ENOUGH TO IMPACT RESULTS. CAREFUL REVIEW OF SERUM CREATININE RESULTS FROM THE AFFECTED INSTRUMENT LINE WAS PERFORMED AND SAMPLES RETESTED, FOLLOWED BY RESULT CORRECTION WHERE INDICATED. A LETTER WAS SENT BY LABORATORY TO PHYSICIANS/CUSTOMERS NOTING THIS EVENT (OVER 300 PATIENTS AFFECTED).ADDITIONAL PROCESS STEPS ADDED AS QUALITY MONITOR. ONCE PER SHIFT A PATIENT SAMPLE WILL BE REPEATED FOR COMPARABLE RESULTS. THIS IS IN ADDITION TO CURRENT PROCESS OF RUNNING KNOWN QUALITY CONTROL SAMPLES DAILY. LAB COMPUTER HAS ACCEPTABLE LIMITS PROGRAMMED TO HALT PATIENT RESULT REPORTING UNTIL A MEDICAL TECHNOLOGIST EVALUATES SUCH NOTIFICATION.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THIS DEVICE MALFUNCTION CAUSED ADVERSE PATIENT EVENTS, I.E. 4 PATIENTS WERE REFERRED TO NEPHROLOGISTS FOR POSSIBLE KIDNEY MALFUNCTION. ====================== MANUFACTURER RESPONSE FOR ROCHE MODULAR AUTOMATION LINE (ANALYTICAL MODULE), ROCHE======================THE SERVICE REPRESENTATIVE CAME TO EVALUATE THE PROBLEM. HE DETERMINED THE CAUSE AS "MECHANICAL FAILURE OF GEAR PUMP" AND REPLACED THE PUMP. AS A PRECAUTIONARY MEASURE HE ALSO REPLACED THE PRESSURE GAUGE.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR STAPH AUREUS IN AN (B)(6) MALE COINCIDENT WITH HOMECHOICE PERITONEAL DIALYSIS THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION: ON (B)(6) 2010, THE PATIENT DEVELOPED AND WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH REVEALED STAPH AUREUS. IT WAS NOT REPORTED WHETHER TREATMENT WAS PROVIDED FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE BELIEVED THE PERITONITIS WAS UNRELATED TO PERITONEAL DIALYSIS THERAPY.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R