BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1782052 · Received August 3, 2010

    Report

    Report Number
    1423500-2010-02068
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY NECESSARY SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE HOME PATIENT CONFIRMED THAT SHE DID NOT NOTICE ANY DEFECTS ON THE SUPPLIES AND THAT THERE WAS NO LEAKS OR LOOSE CONNECTIONS. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT (H10C12015) WITH NO ISSUES NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) WITH TROUBLESHOOTING. THE HP STATED THAT THERE WAS NO SOLUTION IN THE LINE. THE TSR ADVISED THE HP TO DISCONNECT FROM THE SETUP. THE HP WOULD RESTART SETUP WITH ALL NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE HP REGARDING THE ALARM, THE HP EXPLAINED THAT SHE WAS JUST LYING IN BED DURING INITIAL DRAIN WHEN THE ALARM OCCURRED. PER HP, SHE RESUMED THERAPY ON THE MANUALS BECAUSE SHE JUST DID NOT FEEL LIKE GOING BACK ON THE MACHINE. THE HP CONFIRMED THAT SHE DID NOT NOTICE ANY DEFECTS ON THE SUPPLIES, AND THAT THERE WERE NO LEAKS OR LOOSE CONNECTIONS NOTICED EITHER. THE HP STATED THAT SHE DID NOT HAVE ANY PAIN OR INJURY AFTER THE ALARM. THE HP STATED THAT SHE DID NOT KNOW THE LOT NUMBERS. THE HP STATED THAT SHE IS CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED EXPLANTING A DEVICE AFTER AN IMPLANT DURATION OF APPROXIMATELY FIVE YEARS (58.70 MONTHS) DUE TO PATIENT SYMPTOMS "DYSPNEA, FEVER, ENDOCARDITIS, AND CARDIAL DECOMPENSATION". THE PATIENT HAD ENDOCARDITIS IN (B)(6) 2009 AND AGAIN IN (B)(6) 2010. THE SURGEON INDICATED THE MITRAL DEVICE HAD DEGENERATED, WAS STENOTIC AND HE EXPLANTED IT ON (B)(6) 2010. AT EXPLANT, THE DEVICE WAS DESCRIBED AS "PART OF THE RING DAMAGED" BUT THERE WAS NO MENTION OF THE ENDOCARDITIS. THE SOURCE AND TYPE OF INFECTION HAVE NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10C12015

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR