BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1961933 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00674
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ASSIGNABLE CAUSE FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED TO BE RETURNED TO BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. SHOULD THE DEVICE BE RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING NEEDING TO DISCONNECT THE HOME PATIENT (HP), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE CAREGIVER (CG) STATED THAT SHE NEEDED TO GET THE HP DISCONNECTED QUICKLY BECAUSE HE WAS HAVING A HEART ATTACK. DURING A FOLLOW UP CALL ON (B)(6) 2011, THE FACILITY NURSE CONFIRMED THAT THE PATIENT HAD EXPERIENCED A HEART ATTACK (MYOCARDIAL INFARCTION) ON (B)(6) 2010 AND WAS HOSPITALIZED ON THAT DATE. THE ADMITTING DIAGNOSIS WAS VENTRICULAR FIBRILLATION. UNKNOWN PROCEDURES AND LAB TESTS WERE PERFORMED AND NO RESULTS ARE AVAILABLE. THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) ON AN UNKNOWN DATE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2011 IN GOOD CONDITION. THE PATIENT CONTINUED MANUAL THERAPY AND HEMODIALYSIS DURING HOSPITALIZATION. THE PATIENT IS NOW BACK ON PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS SEEN AT THE FACILITY CLINIC ON (B)(6) 2011 AND NOTED TO BE DOING WELL. THE NURSE DID NOT FEEL THE HEART ATTACK WAS CAUSED OR CONTRIBUTED TO BY PERITONEAL DIALYSIS THERAPY DEVICES OR PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R ASPIRIN 325MG DAILY| AMIDERONE 200MG DAILY| (B)(4) 1.5% LO/CAL UB 2.5L/3L, (B)(4) 1.5% LO