BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1991938 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01986
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEUCOCYTE COUNT UNITS WERE RECEIVED ON (B)(6) 2011. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR-POOR ASEPTIC TECHNIQUE. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (GD879908 AND GD881417), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING WITH BAXTER'S TECHNICAL SERVICE CENTER, THE PATIENT'S CAREGIVER (CG) STATED THE HOME PATIENT (HP) DISCONNECTED IN ORDER TO GO TO THE HOSPITAL DUE TO THE SOLUTION HE WAS DRAINING BEING CLOUDY AND THE HP MAY HAVE AN INFECTION. THE TSR ASSISTED THE CG TO END THERAPY ON THE HC. PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS (PD) NURSE ON (B)(4) 2011 REGARDING THE CLOUDY FLUID DURING DRAINING AND THE NURSE STATED THE HP CAME IN TO SEE HER AND THE HP HAS PERITONITIS. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE PATIENT'S PD NURSE ON (B)(4) 2011: THE PATIENT WAS STARTED ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) ON (B)(6) 2010 AND WAS LATER SWITCHED TO AUTOMATED PD THERAPY. THE PATIENT CURRENTLY USES LOCAL (PD4) AMBUFLEX AND LOCAL (PD4) ULTRABAG. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS BUT THE NURSE CLARIFIED THE PATIENT WAS NOT HOSPITALIZED AND THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE PERITONITIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HAS RECOVERED. THE PATIENT'S TRANSFER SET WAS NOT REPLACED AFTER THE PERITONITIS DIAGNOSIS. THE NURSE INDICATED THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE AND THE PATIENT HAS BEEN RETRAINED ON PROPER TECHNIQUE. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE BAXTER PERITONEAL DIALYSIS (PD) SOLUTIONS OR DISPOSABLES. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention LOCAL (PD4) ULTRABAG| HOMECHOICE CYCLER| LOCAL (PD4) AMBUFLEX