BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1885028 · Received October 28, 2010

    Report

    Report Number
    1423500-2010-05010
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED DIFFICULTY OF 9 CYCLES INSTEAD OF 8 WAS CONFIRMED IN THE DEVICE LOGS BUT WAS NOT DUPLICATED DURING EVALUATION. WHEN THE THERAPY IS PROGRAMMED, THE NUMBER OF CYCLES ESTIMATED IS BASED ON: THERAPY VOLUME - LAST FILL VOLUME - FILL 1/TIDAL FILL VOLUME + 1 (TIDAL). IF THE NUMBER OF CYCLES CALCULATED IS NOT A WHOLE NUMBER, THE HOMECHOICE SYSTEM WILL ESTIMATE THE NUMBER OF CYCLES BASED ON THE FOLLOWING RULE: IF THE FRACTION IS > .85, IT WILL ROUND UP NUMBER OF CYCLES. IF THE FRACTION IS < .85, IT WILL DROP THE DECIMAL PORTION OF THE NUMBER OF CYCLES. FOR THIS THERAPY, NUMBER OF CYCLES = 8000ML 1100ML / 880ML + 1 = 8.84 CYCLES (ROUNDS OFF TO 8 CYCLES). THE CALCULATION OF THE NUMBER OF REMAINING CYCLES IS PERFORMED PRIOR TO EVERY FILL CYCLE. AN INCREASE IN REMAINING FLUID VOLUME CAN INCREASE THE ESTIMATED NUMBER OF CYCLES. THE DEVICE DETECTED ADDITIONAL REMAINING FLUID AT THE END OF DRAIN 6 OF 8 AND INCREASED THE NUMBER OF CYCLES FROM 8 TO 9. THE CAUSE OF THE REPORTED DIFFICULTY OF 9 CYCLES INSTEAD OF 8 WAS DETERMINED TO BE NORMAL DEVICE FUNCTION: THERAPY WAS RECALCULATED BASED ON THE VOLUME OF FLUID REMAINING IN ORDER TO FINISH WITHIN THE PROGRAMMED PARAMETERS. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED ISSUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED A PROGRAMMING ISSUE WITH THE HOMECHOICE (HC) MACHINE. THE HOME PATIENT (HP) STATED THAT THE HC WENT FROM EIGHT CYCLES TO NINE CYCLES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED TO SWAP THE HC. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2010. THE PATIENT STATED THERE WAS NO RE-PROGRAMMING MADE TO THE DEVICE. THE PATIENT STATED THAT THE CYCLER WOULD CHANGE INTO 9 CYCLES FROM 8 CYCLES, HOWEVER, THIS DID NOT OCCUR AT EVERY THERAPY. THE PATIENT RECEIVED A NEW CYCLER AND IS HAVING NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR