BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1875193 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04632
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) THAT OCCURRED DURING DWELL 1 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. A LABELING REVIEW FOUND THE HOMECHOICE USER'S MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE SPOKE WITH PERITONEAL DIALYSIS NURSE (PDN) WHO VERIFIED THAT THE PATIENT DID NOT DEVELOP ANY TYPE OF SYMPTOMS AS A RESULT OF THIS INCIDENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE PDN STATED THAT THE PATIENT IS FINE AND SHE HAD REVIEWED PROPER PROCEDURE. THE PDN ADVISED THAT THE PATIENT FINISHED THE BOX OF SUPPLIES WITH NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 1. THE CG STATED THE HOME PATIENT (HP) DISCONNECTED DURING DWELL AND RECONNECTED, BUT HC WAS ALREADY IN DRAIN 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE HP CAN DISCONNECT DURING DWELL, BUT HAS TO RECONNECT BEFORE DWELL TIME ENDS. THE TSR EXPLAINED SE 2240 INDICATES LARGE AMOUNT OF AIR HAS ENTERED CASSETTE AND ADVISED THE CG TO CYCLE POWER TO CLEAR THE ALARM. THE CG STATED SHE DID NOT HAVE MANUAL SUPPLIES, SO ELECTED TO END THERAPY. THE TSR ADVISED THE CG TO INFORM THE PERITONEAL DIALYSIS NURSE (PDRN) OF THE ALARM AND ANY MISSED THERAPY. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE CG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 92 YR