BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1953009 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00257
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. RESULTS INDICATE: THE REPORTED ISSUE OF SE 2045 (NEGATIVE P TANK HIGH) WAS CONFIRMED IN THE DEVICE LOGS BUT NOT DUPLICATED DURING THE EVALUATION. THE REPORTED ISSUE OF POSSIBLE AIR INFUSION IS UNABLE TO BE CONFIRMED IN THE LOGS OR DUPLICATED. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. THREE PRIMING SEQUENCES WERE PERFORMED AND COMPLETED SUCCESSFULLY. THE DEVICE PASSED THE AIR DETECTION CHECK . AIR WAS INTENTIONALLY DRAWN INTO THE CASSETTE DURING EACH PHASE AND THE DEVICE ALARMED WITH A SE 2240, FOLLOWED BY A SE 2367 WHEN THE POWER WAS CYCLED. AT NO TIME DID THE DEVICE DELIVER AIR INTO THE PATIENT LINE. A LOW BATTERY MESSAGE WAS ENCOUNTERED WHEN THE DEVICE WAS POWERED ON. THE LEAD ACID BATTERY WAS REPLACED WITH THE TEST ARTICLE AND THE LOW BATTERY MESSAGE CLEARED. A REVIEW OF THE DEVICE LOGS REVEALED NO INDICATION OF AIR INFUSION OR ANY INSTANCES OF IIPV (INCREASED INTRA-PERITONEAL VOLUME). MULTIPLE BATTERY FAILED ENTRIES WERE FOUND IN THE LOGS. THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUES OF SE 2045 AND POSSIBLE AIR INFUSION WAS UNDETERMINED. THE ASSIGNABLE CAUSE FOR THE LOW BATTERY / BATTERY FAILED WAS DETERMINED TO BE THE LEAD ACID BATTERY. THE DEVICE'S SERVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE POSSIBLE AIR INFUSION. 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 FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION AND/OR IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND STATED HER OLD HOMECHOICE (HC) DEVICE MAY HAVE PUT AIR IN HER BODY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE DISPOSABLE SUPPLIES, CASSETTE AND BAGS ARE WHAT THE FLUID MOVES THROUGH AND THE HC DEVICE JUST PULLS ON THE OUTSIDE OF THE CASSETTE SHEETING. THE TSR EXPLAINED THE ONLY WAY AIR COULD GET TO THE HP WOULD BE IF THERE WAS AIR IN THE PATIENT LINE AFTER THE PRIME COMPLETED AND THE HP CONNECTED TO THE MACHINE. THE HP UNDERSTOOD, AND STATED HER NEW HC DEVICE HAS BEEN WORKING GREAT. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2010 REGARDING THE REPORT OF THE HC DEVICE PUSHING AIR INSIDE HER, WHICH OCCURRED ON (B)(6) 2010 (THE HP DID NOT CALL IN THE EVENT UNTIL AFTER (B)(6) 2010). THE HP STATED THAT THE HC HAD PUSHED A LOT OF AIR INSIDE HER AND SHE WAS IN EXTREME PAIN. THE HP WENT IN TO HER CLINIC THE NEXT DAY AND SAW HER DOCTOR WHO RECOMMENDED THAT THE HP GO TO THE EMERGENCY ROOM FOR TESTING. THE HP WENT TO THE EMERGENCY ROOM AND HAD AN ULTRASOUND AND X-RAY DONE. THE DOCTOR AT THE ER STATED THAT SHE HAD A "TON OF AIR" INSIDE HER. THE HP CONTINUED THERAPY USING MANUALS. THE HP MENTIONED THAT SHE HAS LITTLE KIDNEY FUNCTION AND HER CLINIC DIRECTED HER TO GO BACK ON THE HC DEVICE. THE HP STATED THAT THE ISSUE WAS RESOLVED WHEN SHE GOT A NEW HC DEVICE. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE HP STATED THAT SHE IS DOING FINE WITH HER NEW HC DEVICE, CONTINUING THERAPY WITHOUT ISSUES. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE HP'S PRIMARY PERITONEAL DIALYSIS (PD) NURSE ON (B)(6) 2011: THE NURSE INDICATED THAT IN HIS OPINION, ALTHOUGH THE HP BELIEVES IT IS THE HC DEVICE THAT CAUSED THE AIR, THE CAUSE OF THE HP HAVING AIR IS THAT THE HP DOES NOT ALLOW THE DISPOSABLE TO PRIME PROPERLY. THE NURSE INDICATED THAT THE HP REFUSES TO MAKE AN APPOINTMENT TO GET RETRAINED ON PROPER PRIMING OF HER DISPOSABLES. THE NURSE ALSO INDICATED THAT THERE HAS BEEN NO RECURRENCE OF THIS AND THE HP HAS BEEN ABLE TO CONTINUE PD THERAPY WITHOUT ANY FURTHER ISSUES SINCE SHE RECEIVED HER REPLACEMENT HC DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE HP'S NURSE INDICATED THE HP DECLINED RECOMMENDED TREATMENT FOR THE AIR FOUND INSIDE HER, WHICH WAS TO DRAIN WITH HER HIPS HIGHER THAN HER ABDOMEN. THE PATIENT IS ON 2.4 L AT 85% TIDAY THERAPY WITH 2L IN LAST FILL EVERY NIGHT AND 2.1 L ULTRABAG EVERY DAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R