BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2223498 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11253
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT FOR PERITONITIS IS CONFIRMED DUE TO A TOUCH CONTAMINATION REPORTED BY THE DIALYSIS NURSE IN THE BAXTER GLOBAL PHARMACOVIGILANCE REPORT . THE ASSIGNABLE ROOT CAUSE FOR TOUCH CONTAMINATION IS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT H11D29107 AND AN EXCEPTION WAS NOTED. HOWEVER, THE EXCEPTION DID NOT INDICATE ANY ISSUES RELATED TO THE COMPLAINT. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. A LABELING REVIEW WAS PERFORMED ON THE HOMECHOICE AT-HOME PATIENT GUIDE. THE PATIENT AT HOME GUIDE INCLUDED WITH THE HOMECHOICE DEVICE PROVIDES SUFFICIENT LABELING FOR USERS TO BE AWARE OF PROPER ASEPTIC TECHNIQUE TO REDUCE THE CHANCE OF CONTAMINATION AND THUS PERITONITIS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED

    Description of Event or Problem · 1

    INITIALLY THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HOME CHOICE (HC), LOW DRAIN VOLUME ALARM, WHICH OCCURRED DURING THERAPY DURING THE INITIAL DRAIN. THE PERITONEAL DIALYSIS NURSE (PDN) CLEARED THE ALARM AND THE DRAIN WAS COMPLETED THEREFORE, NO TROUBLESHOOTING WAS REQUIRED. THERE WAS NO REPORT OF PATIENT INJURY OR NEED FOR MEDICAL INTERVENTION AT THE TIME OF THE INITIAL CALL. ON (B)(6) 2011 BAXTER PRODUCT SURVEILLANCE (PS) CONTACTED THE PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE LOW DRAIN VOLUME ALARM AND A REPORT OF PATIENT HOSPITALIZATION. PER THE PDN, THE HP WAS HAVING ABDOMINAL PAIN AND WENT IN THE HOSPITAL FOR PERITONITIS. NO FURTHER INFORMATION WAS GIVEN AT THE TIME OF THIS FOLLOW UP CALL. ON (B)(6) 2011, PS CONTACTED THE PDN TO FOLLOW UP ON THE REPORT OF PERITONITIS. THE FOLLOWING INFORMATION WAS RECEIVED. ON AN UNSPECIFIED DATE IN (B)(6) 2011 THE PATIENT (AGE NOT REPORTED) WAS DIAGNOSED WITH BACTERIAL PERITONITIS. THE PDN REPORTED THAT ON AN UNSPECIFIED DATE, THE HOME PATIENT (HP) WAS EXPERIENCING ABDOMINAL PAIN AND WENT TO THE HOSPITAL IN THE NIGHT. THE HP WAS HOSPITALIZED ON (B)(6) 2011 AND WAS DISCHARGED ON (B)(6) 2011. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE, FREQUENCY, ROUTE, NOT REPORTED). THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THE EVENT. DIANEAL LOCAL (B)(4) THERAPY WAS ONGOING. ON AN UNREPORTED DATE, THE PATIENT RECOVERED. THE PDN STATED THE CAUSE WAS PROBABLY DUE TO A BREAK IN ASEPTIC TECHNIQUE. IT WAS NOT REPORTED IF RETRAINING IN ASEPTIC TECHNIQUE WAS DONE. THE PDN DECLINED TO PROVIDE ANY CONCOMITANT MEDICATIONS. THE PDN STATED THAT SHE DID NOT BELIEVE THE CAUSE OF THE PERITONITIS WAS RELATED TO A BAXTER DEVICE OR SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R DIANEAL LOCAL 2.5%