BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 FOOT EXTENSION SET EASYLOCK CONNECTOR

    MDR report key: 1891253 · Received November 4, 2010

    Report

    Report Number
    1423500-2010-05253
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBER; H10G19094 AND H10F10012 WITH NO DEFECTS NOTED. THE DETERMINED CAUSE WAS POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. 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

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PATIENT WHO MADE A MISTAKE/TOUCH CONTAMINATION (CODED TO PERITONEAL DIALYSIS COMPLICATION) AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM, GRAM NEGATIVE ORGANISM, AND STAPHYLOCOCCUS EPIDERMIDIS IN PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. ON (B)(6) 2010, THE PATIENT BECAME SICK AGAIN, WHICH DID NOT INVOLVE HOSPITALIZATION. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. THE NURSE DID NOT PROVIDE INFORMATION REGARDING TREATMENT. DIANEAL THERAPIES WERE ONGOING AT THE TIME OF THE EVENTS. THE PATIENT WAS RECOVERING FROM THE EVENTS. IT WAS NOT REPORTED WHETHER THE EVENT OF PATIENT TOUCH CONTAMINATION RESOLVED. PER THE NURSE, THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM, GRAM NEGATIVE ORGANISM, AND STAPHYLOCOCCUS EPIDERMIDIS WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION WITH REGARDS TO DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND HAD THE PATIENT CYCLE POWER TWICE TO CLEAR IT. GTS THEN EXPLAINED THAT THE PATIENT NEEDED TO START OVER WITH NEW SUPPLIES AND THAT THEY WOULD NEED TO CALL THEIR DIALYSIS NURSE WITHIN 24 HOURS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization