BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12 FOOT EXTENSION SET EASYLOCK CONNECTOR

    MDR report key: 1821966 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03046
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WAS AVAILABLE TO CONFIRM THE REPORTED ISSUE OF SEPARATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE CAUSE OF THE SEPARATION WAS IDENTIFIED AS EXCESSIVE FORCE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 1 OF 5. THE HOME PATIENT (HP) STATED THAT HIS EXTENSION LINE FOR THE PATIENT LINE SOMEHOW BECAME DISCONNECTED DURING THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ASSISTED WITH TROUBLESHOOTING THE ALARM. THE TSR ADVISED THE HP TO START OVER AGAIN USING NEW SUPPLIES. DURING A FOLLOW UP WITH THE HP'S DAUGHTER REGARDING THE SEPARATION, IT WAS REVEALED THAT THE EXTENSION LINE MIGHT HAVE TANGLED-UP IN HP'S FEET. PER THE DAUGHTER, THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE DAUGHTER ADDED THAT A HOME NURSE HAD ALSO VISITED THE HP, AND SHE ADVISED THAT HP WAS DOING FINE. PER DAUGHTER, HP WAS CONTINUING THERAPY WITHOUT ISSUES. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12 FOOT EXTENSION SET EASYLOCK CONNECTOR SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H10E12051

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR