BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2233374 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11650
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PROBLEM WAS CONFIRMED BASED ON INFORMATION OBTAINED DURING THE INVESTIGATION WHICH INDICATED A MISTAKE/TOUCH CONTAMINATION RESULTING IN A BREACH IN ASEPTIC TECHNIQUE; HOWEVER, NO ASSIGNABLE CAUSE FOR THE BREACH IN ASEPTIC TECHNIQUE COULD BE DETERMINED A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT H11E08025 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. A LABELING REVIEW WAS PERFORMED ON THE HOMECHOICE AT-HOME PATIENT GUIDE. THE HOMECHOICE AT-HOME PATIENT GUIDE LABELING GIVES RELEVANT INFORMATION REGARDING INSTRUCTIONS FOR USE. THE INSTRUCTIONS ARE CLEARLY LABELED AND ARE FOUND IN THE PROVIDED MANUAL. THE INSTRUCTIONS ARE ACCURATE AND PROVIDE A SUFFICIENT LEVEL OF DETAIL. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THE TIME OF THIS REPORT THE NURSE REPORTED THE PATIENT IS RECOVERING.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM BAXTER GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS CAPITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE CONSUMER REPORTED THE CAUSE OF THE PERITONITIS WAS THE LUER CONNECTION. TREATMENT INFORMATION WAS NOT REPORTED. THE OUTCOME OF THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION WAS UNKNOWN. DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2011, FOLLOW UP INFORMATION WAS RECEIVED FROM THE PD NURSE. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED. TREATMENT INCLUDED A LOADING DOSE OF VANCOMYCIN, 3 GM, IP (START DATE NOT REPORTED) AND THEN IP VANCOMYCIN, 1500MG EVERY 5 DAYS (START/STOP DATES NOT REPORTED). THE PATIENT WAS THEN SWITCHED TO IV VANCOMYCIN (DOSE, FREQUENCY AND START/STOP DATES NOT REPORTED). AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED AND HAD NOT RECOVERED DUE TO THE PATIENT NOT GOING TO THE HOSPITAL RIGHT AWAY. ON AN UNSPECIFIED DATE IN (B)(6) 2011, DIANEAL THERAPY WAS WITHDRAWN. THE PATIENT WAS SCHEDULED TO BEGIN HEMODIALYSIS FOR 6-8 WEEKS BECAUSE THE PATIENT'S CATHETER WAS TO BE REMOVED. THE PATIENT'S PD CATHETER IS TO BE REPLACED AT A LATER, UNKNOWN DATE. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY FOR THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION WAS NOT PROVIDED. ON (B)(4) 2011, BAXTER PRODUCT SURVEILLANCE CONTACTED THE PD NURSE TO OBTAIN FURTHER INFORMATION AND THE PD NURSE DECLINED TO PROVIDE ANY FURTHER PATIENT INFORMATION.

    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 64 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX