BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUARIUS RCA W/CITRATE MODULE

    MDR report key: 1914772 · Received December 3, 2010

    Report

    Report Number
    1423500-2010-06517
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE DEVICE WILL BE REPAIRED ONSITE BY A FIELD SERVICE ENGINEER.

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER REPORTED AN ISSUE WITH A CITRATE PUMP FAILURE WITH NO ALARM. UPON INVESTIGATION, THE REPORTED ISSUE WAS CONFIRMED. THE CAUSE WAS DETERMINED TO BE A BROKEN CITRATE PUMP COUPLING. THE PUMP WAS REPLACED AND THE SCALES WERE RECALIBRATED TO CORRECT THE ISSUE. THE DEVICE IS OPERATIONAL AND READY FOR USE AT THE CUSTOMER FACILITY. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS NECESSARY. THE CITRATE PUMP COUPLING PART FAILURE IS A KNOWN ISSUE AND IS BEING ADDRESSED BY THE SUPPLIER ((B)(4)) THROUGH A DESIGN CHANGE PROJECT. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CITRATE PUMP HAD FAILED DURING PATIENT TREATMENT BUT DID NOT CAUSE ANY ERROR OR ALARM. MEDICAL INTERVENTION HAS BEEN REPORTED AS THE CITRATE PUMP STOPPED, BUT THE CALCIUM/MAGNESIUM PUMP KEPT GOING WHICH RESULTED IN THE PATIENT NEEDING TO BE TAKEN OFF CITRATE THERAPY AND REVERTING TO HEPARIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUARIUS RCA W/CITRATE MODULE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1