BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1623511 · Received March 8, 2010

    Report

    Report Number
    1423500-2010-00197
    Event Type
    Injury
    Date Received
    March 8, 2010
    Date of Event
    November 22, 2009
    Report Date
    February 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE PATIENT HAS DECLINED TO RETURN THE HOMECHOICE DEVICE TO BAXTER FOR EVALUATION. DUE TO THE PATIENT ALLEGATION OF CAUSALITY OF INJURY AS A RESULT OF THE HOMECHOICE DEVICE, THIS COMPLAINT IS BEING REPORTED AS A SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT RELEASED THE DEVICE TO BAXTER FOR EVALUATION. THE EVALUATION RESULTS INDICATE: THE HOMECHOICE DEVICE WAS EVALUATED FOR THE REPORTED DIFFICULTIES OF PATIENT SYMPTOMS. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THESE REPORTED DIFFICULTIES. THE DEVICE WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE PASSED THE HOMECHOICE RITE FUNCTIONAL TEST AND THE HOMECHOICE RITE ELECTRICAL TEST. DUE TO ADDITIONAL THERAPIES BEING PERFORMED AND OVERWRITING THE PREVIOUS DATA, THERE IS NO INFORMATION WITHIN THE LOGS FROM THE DATE OF THE REPORTED DIFFICULTIES. THESE REPORTED DIFFICULTIES WERE UNABLE TO BE CONFIRMED DURING THE PAL EVALUATION. ISSUES SUCH AS THIS ARE PATIENT SYMPTOM IN NATURE AND WOULD NOT BE RECORDED IN THE LOGS OR REPRODUCIBLE IN THE LAB. THE ASSIGNABLE CAUSE IS UNDETERMINED. (B)(4) IS CURRENTLY OPEN TO ADDRESS OVERFILL / IIPV.

    Description of Event or Problem · 1

    INITIALLY, AN EMAIL WAS RECEIVED IN THE CORPORATE MAILBOX ON FEBRUARY 23, 2010. THE PATIENT HAD CALLED AND STATED HE DID NOT WANT THE CYCLER PICKED UP BECAUSE THE DOCTOR AND LAWYER NEED IT DUE TO A LAWSUIT THAT IS GOING ON. THE PATIENT STATED HE HAD HAD A HEART ATTACK AND BELIEVES IT WAS DUE TO THE HOMECHOICE CYCLER. ADDITIONAL INFORMATION RECEIVED ON 02/24/10 INDICATES THE FOLLOWING: MESSAGE RECEIVED FROM (B) (4) MANAGER ON 02/23/10 INDICATING THAT HER DEPARTMENT NOTED THE PATIENT HAD BEEN INACTIVATED IN THE SYSTEM. A FOLLOW UP CALL WAS PLACED TO DETERMINE IF THE HOMECHOICE DEVICE WOULD BE RETURNED TO BAXTER. THE (B) (4) REPRESENTATIVE WAS ADVISED BY THE PATIENT THAT HE HAD HAD A HEART ATTACK AND FEELS THAT IT WAS RELATED TO THE HOMECHOICE DEVICE BASED ON THE SIGNS AND SYMPTOMS NOTED IN A RECALL LETTER SENT TO THE CUSTOMER. THE PATIENT INDICATED HE HAS SOUGHT LEGAL COUNSEL AND BEEN ADVISED TO NOT RELEASE THE DEVICE TO BAXTER. THE PATIENT INDICATED HE DECLINES TO RELEASE THE DEVICE TO BAXTER. ADDITIONAL INFORMATION RECEIVED FROM THE WALTER REED MEDICAL CENTER CLINIC INDICATES THE FOLLOWING: THE PATIENT CAME TO THE (B) (6) ON (B) (6) 2010 WITH A COPY OF THE URGENT RECALL LETTER FROM BAXTER. THE PATIENT ALLEGED HE EXPERIENCED THE SYMPTOMS NOTED WITHIN THE RECALL LETTER. REPORTEDLY THE PATIENT EXPERIENCED NAUSEA, VOMITING AND A FEELING OF FULLNESS FOR TWO DAYS PRIOR TO GOING TO THE EMERGENCY DEPARTMENT ON (B) (6) 2009. THE PATIENT WAS SEEN AT THE (B) (6) EMERGENCY DEPARTMENT ON (B) (6) 2009 DUE TO NAUSEA, VOMITING, AND DYSPNEA AND TO RULE OUT A POSSIBLE MYOCARDIAL INFARCT (MI). THE PATIENT WAS TRANSFERRED TO (B) (6) ON (B) (6) 2009 WHERE HE WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS NOTED TO HAVE A BLOOD GLUCOSE OF GREATER THAN 750 AT THE TIME OF ADMISSION. THE PATIENT WAS FOUND TO HAVE PULMONARY EDEMA, PITTING EDEMA OF THE EXTREMITIES AND CRACKLES IN THE LUNGS. THE BLOOD PRESSURE (BP) AT THAT TIME WAS 200/114. THE CARDIAC ENZYMES WERE NOTED TO BE ONLY SLIGHTLY ELEVATED. NO FURTHER INFORMATION WAS PROVIDED REGARDING LABS AND MEDICAL INTERVENTIONS. THE NURSE INDICATED THERE WAS NO INFORMATION TO SUPPORT THAT THE PATIENT HAD A HEART ATTACK. THE HOSPITAL NOTES INDICATED THAT THE PATIENT WOULD HAVE HIS CAD MEDICALLY MANAGED UPON DISCHARGE. THE PATIENT WAS DISCHARGED TO HOME ON (B) (6) 2009 AND CONTINUED ON PERITONEAL DIALYSIS UNTIL (B) (6) 2009 WHEN HE WAS TRANSFERRED TO HEMODIALYSIS THREE TIMES/WEEK FOR THREE AND ONE HALF HOURS PER THERAPY TREATMENT. THE NURSE INDICATED THERE WAS NO EVIDENCE OF OVERFILL AND THAT THE PATIENT TYPICALLY WAS EMPTY DURING THE DAY. THE PATIENT DID NOT PROVIDE THE DEVICE LOG TO THE CLINIC PERSONNEL. THE NURSE INDICATED THE PATIENT HAS A SIGNIFICANT CARDIAC HISTORY. THE PATIENT STATUS INDICATES HE IS CURRENTLY STABLE ON HEMODIALYSIS THERAPY. THE PATIENT HAD CALLED THE CLINIC ON (B) (6) 2009 STATING HE WAS FEELING 'FULL' AND REQUESTED HIS PERITONEAL FLUID VOLUME BE DECREASED. AT THIS TIME, THE PATIENT'S PRESCRIPTION WAS FOR 2000ML OVER NINE HOURS. THE NURSE HAD THE PATIENT MANUALLY DRAIN. THE PATIENT FILLED WITH 2000ML AND THE DRAIN VOLUME WAS 2000ML. THE NURSE DECREASED THE FILL VOLUME TO 1700ML. THIS PATIENT WAS RECEIVING DIANEAL 1.5%. THE NURSE INDICATED THAT THE PATIENT'S BLOOD SUGAR IS NOT STABLE, HIS DIABETES IS DIFFICULT TO MANAGE AND HE IS A 'BRITTLE' DIABETIC. HIS BLOOD SUGARS FLUCTUATE FROM VERY LOW TO GREATER THAN 700. THE NURSE INDICATED HE DOES NOT SEE EVIDENCE OF A POSSIBLE LINK TO THE DEVICE AND THE PATIENT SYMPTOMS.

    Description of Event or Problem · 1

    THE LAY USER/ PT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS UNK ERROR MESSAGE. THE REPORTER WAS UNABLE TO RECALL THE ERROR MESSAGE DISPLAYED. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R