BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1914764 · Received December 3, 2010

    Report

    Report Number
    1423500-2010-06510
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS NOT DETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. 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 GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING INITIAL DRAIN. GTS HAD THE HOME PATIENT (HP) CHECK THE PATIENT LINE AND THE HP STATED THAT THERE WAS AIR IN THE LINE. GTS HAD THE HP CYCLE POWER AND A SYSTEM ERROR 2367 ALARM OCCURRED. GTS ADVISED THE HP TO CYCLE POWER AGAIN AND RESTART THE SETUP WITH ALL NEW SUPPLIES. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(4) 2010, GLOBAL PRODUCT SURVEILLANCE SPOKE WITH THE HP REGARDING THE REPORTED PROBLEM. THE NURSE WAS AWARE OF THE REPORTED PROBLEM. THE HP STATED THAT SHE HAD SPOKEN WITH HER NURSE, AND SHE WAS THE ONE THAT ADVISED HER TO CALL BAXTER. THE HP DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THE LOT NUMBER WAS UNKNOWN AND THE SAMPLE WAS NOT AVAILABLE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR