BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 2132627 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07753
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. THIS CODE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND THEREFORE DOES NOT HAVE A 510K NUMBER. THIS DEVICE IS THE SAME OR SIMILAR TO A DEVICE MANUFACTURED, SOLD OR DISTRIBUTED IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS INVESTIGATED IN THE BAXTER (B)(4) CENTRAL WORKSHOP ON (B)(4) 2011. THE REPORTED ISSUE WAS NOT CONFIRMED NOR REPRODUCED. ISSUE WAS NOT CONFIRMED IN EVENT LOG FILE AS EVENT LOG WAS NOT AVAILABLE FOR EVALUATION. EVENT LOG WAS NOT AVAILABLE FOR EVALUATION AS A HARDWARE PROBLEM OCCURRED DURING MOVING OF THE EVENT LOG. THE DEVICE WAS FULLY OPERATIONAL DURING EVALUATION. THE HEATER PLATE WAS CHANGED TO NEW ONE AS A COSMETIC MATTER DUE TO SCRATCHES ON PAINT SURFACE. THE DEVICE WAS FULLY TESTED AND CALIBRATED (PRESSURE, TEMPERATURE, VOLUMETRIC) DURING EVALUATION, NO PROBLEMS WERE OBSERVED WITH BAG/FLUID TEMPERATURE. THE ROOT CAUSE OF COMPLAINT CANNOT BE DETERMINED. BAXTER WILL MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM WITH THIS PUMP.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED BY BAXTER TECHNICAL SERVICES REPRESENTATIVE (TSR) ON (B)(6) 2011 FROM THE CAREGIVER OF A MALE PATIENT (AP), WHO ATTENDS THE (B)(6) COLLEGE HOSPITAL. THE CAREGIVER (CG) STATED THE PATIENT CALLED HIM AND STATED HE WAS USING THE HOMECHOICE DEVICE AND THE FLUID WAS EXTREMELY HOT GOING INTO HIS BODY. WHEN CG GOT TO HP'S HOME THE MACHINE HAD MOVED TO DWELL 1. THE TUBING AND BAG OF FLUID ON HEATER WAS EXTREMELY HOT TO THE TOUCH. THEY DID NOT TURN MACHINE OFF. NO ALARMS WERE NOTED. NO TEMPERATURE STABILIZING WARNING WAS RECEIVED. THE CG STATED THE DEVICE THEN MOVED INTO DRAIN 1 AND REFILLED FILL 2. THE MACHINE WAS THEN ON DWELL 2 AND HP WAS NOTED TO BE COUGHING UP BLOOD. THE TSR HAD CG REMOVE PATIENT FROM MACHINE AND ADVISED TO SEEK MEDICAL ATTENTION. THE MACHINE WAS USED WITH AN UNKNOWN PD SET (PRODUCT CODE UNKNOWN, LOT UNKNOWN) AND PD BAGS (PRODUCT CODE UNKNOWN, LOT UNKNOWN). CLINICAL CONSEQUENCES FOR THE PATIENT WERE NOT INITIALLY REPORTED. IT IS UNKNOWN WHAT INTERVENTIONS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL NURSE AND INDICATES: THE CASE CONCERNS A MALE PATIENT WHO WAS RECEIVING ASSISTED APD WITH PHYSIONEAL 40 1.36% IN CLEARFLEX BAGS AND EXTRANEAL. THE PATIENT HAD PRESENTED THE NURSE WITH THE TISSUES HE HAD KEPT TO SHOW THE BLOOD HE HAD COUGHED UP AND AFTER LOOKING AT THESE THE NURSE FELT THAT THE PATIENT COUGHING UP BLOOD WAS UNRELATED TO HIS PD THERAPY AND WAS RELATED TO HIS UNDERLYING CONDITION AND PRIOR BIOPSY. ON (B)(6) 2011, THE PATIENT WAS UNDERGOING A FILL WITH PHYSIONEAL 40 1.36% IN CLEARFLEX WHEN HE EXPERIENCED SEVERE ABDOMINAL PAIN DESCRIBED AS "BURNING FROM THE INSIDE OUT." THE PATIENT'S SON REPORTED THE HOMECHOICE LINES WERE EXTREMELY HOT TO TOUCH, HOWEVER THE HEATER PLATE OF THE MACHINE WAS NO HOTTER THAN NORMAL. THE PATIENT WAS ALSO COUGHING UP SMALL AMOUNTS OF BLOOD. THE PATIENT WAS SEEN IN THE RENAL UNIT THE FOLLOWING MORNING AND WAS EXAMINED. HE WAS "NOT WORSE FOR WEAR" AND THE REPORTING NURSE STATED THAT THEY DID NOT HAVE ANY CONCERNS FOLLOWING HIS EXAMINATION. BLOOD PRESSURE WAS NORMAL FOR HIM AT 152/81, PULSE RATE 64 AND STEADY; HE HAD NOT EXPERIENCED ANY DRAIN OR FILL PAIN AND DID NOT EXHIBIT CLOUDY EFFLUENT. HIS ABDOMEN SHOWED NO REBOUND, WAS SOFT, SHOWED NO PAIN, TENDERNESS OR SYMPTOMS OF HARM. HE HAD GOOD BOWEL SOUNDS AND GOOD PERISTALSIS. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED. THE REPORTING NURSE CONSIDERED THAT THE EVENTS WERE RELATED TO SUSPECTED MALFUNCTION OF THE HOMECHOICE MACHINE AND WERE UNRELATED TO THE PATIENT'S PERITONEAL DIALYSIS (PD) FLUIDS. THE BATCH AND SERIAL NUMBERS WERE NOT AVAILABLE FOR THE PATIENT'S LINE-SET, HOWEVER THE SAMPLES THAT HAD BEEN BROUGHT INTO THE RENAL UNIT WERE "CLOSED" AND THERE APPEARED TO BE NOTHING WRONG WITH THEM. THE PATIENT'S SON REPORTED THAT THE LINES HAD "GONE FLOPPY" WITH THE HEAT AND THEIR CONSISTENCY HAD CHANGED. THE SEAL OF THE PHYSIONEAL BAGS HAD NOT BEEN FULLY BROKEN. THE SEAL WAS BROKEN IN THE MIDDLE BUT THE SIDES WERE STILL SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 2L EXTRANEAL| PHYSIONEAL 40 1.36% IN 5L CLEARFLEX