BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1873160 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04579
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT (GD874859) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON 10/25/2010 THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED BY GLOBAL PHARMACOVIGILANCE. IT WAS ALSO INDICATED THE PATIENT WAS ALSO TREATED WITH KEFLEX (500MG EVERY EIGHT HRS, BY MOUTH) FOR THE PERITONITIS. THE PATIENT WAS CONSIDERED RECOVERED FROM THE EVENT ON (B)(6) 2010. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WILL NOT COMPLETE BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING WANTING TO MANUALLY DRAIN THE HOME PATIENT (HP) AND END THERAPY. THE HOMECHOICE DEVICE WAS IS IN DWELL 1. THE TECHNICAL SERVICE CENTER (TSR) HAD THE PATIENT'S CAREGIVER (CG) STOP THE DWELL AND THEN START THE MANUAL DRAIN. THE CG STATED THE HP HAS AN INFECTION AND WANTED TO TAKE HER TO THE HOSPITAL AFTER DRAINING. THE HOMECHOICE WAS OPERATIONAL. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE PATIENT'S PERITONEAL DIALYSIS (PD) NURSE ON (B)(6) 2010: THE PATIENT STARTED ON PD THERAPY WITH LOCAL (PD4) AMBUFLEX ON (B)(6) 2007. THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2010 AND WAS HOSPITALIZED FROM (B)(6) 2010 UNTIL (B)(6) 2010. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THIS PERITONITIS EVENT. A GRAM STAIN AND CULTURE WERE PERFORMED ON THE PATIENT'S PD EFFLUENT. THE GRAM STAIN SHOWED NO ORGANISM, ONLY A FEW WHITE BLOOD CELLS AND THE CULTURE SHOWED (B)(6). THE NURSE INDICATED THAT THE PATIENT WAS TREATED WITH FLAGYL AND LEVAQUIN (ROUTE AND DOSAGE NOT PROVIDED) AND HAS RECOVERED FROM THE PERITONITIS EVENT. THE NURSE INDICATED THE CAUSE OF THE PERITONITIS WAS LIKELY DUE TO A BREAK IN ASEPTIC TECHNIQUE AND THERE WAS NO ALLEGATION MADE AGAINST ANY OF THE PATIENT'S BAXTER PD SOLUTIONS OR DEVICES. THE NURSE ALSO INDICATED THAT THE PATIENT'S TRANSFER SET WAS NOT REPLACED AFTER THE PERITONITIS DIAGNOSIS AND THE PATIENT HAS BEEN ABLE TO CONTINUE WITH PD THERAPY WITHOUT ANY FURTHER PROBLEMS. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R