BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3540252 · Received December 27, 2013

    Report

    Report Number
    1416980-2013-35801
    Event Type
    Injury
    Date Received
    December 27, 2013
    Date of Event
    November 18, 2013
    Report Date
    December 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS CANNOT BE COMPLETED. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13H12110, H13I01038, H13I30102 WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THIS REPORT REFERENCES THE SAME PATIENT AS CMPLNT(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED 3 DAYS AFTER ONSET. TREATMENT WAS NOT REPORTED. ON AN UNKNOWN DATE, THE PD CATHETER WAS REMOVED DUE TO COLONIZATION AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE CAUSE OF THE PERITONITIS WAS ASSUMED TO BE A TOUCH CONTAMINATION, BUT WAS NOT CONFIRMED. THE PATIENT WAS DISCHARGED 6 DAYS LATER AND WAS RECOVERING FROM PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT. EVENT DETAILS: DURING A CALL, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD CATHETER CONTAMINATED. TREATMENT WAS NOT REPORTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS CATHETER CONTAMINATION. ON (B)(6) 2013, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED AND THE RESULT WAS FOUND TO BE POSITIVE FOR (B)(6). TREATMENT WAS NOT REPORTED. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS STILL DOING HEMODIALYSIS AT CLINIC. OUTCOME: PERITONITIS WITH CULTURE POSITIVE FOR (B)(6): RECOVERING/RESOLVING AND CATHETER CONTAMINATED: NOT REPORTED. MEDICAL HISTORY: SEIZURE, HYPEROSMOLAR, UNCONSCIOUS AND SUGAR FOUND MORE THAN 1000 (CASE (B)(4)), END STAGE RENAL DISEASE (ESRD), HYPERTENSION AND DIABETES. CONCOMITANT THERAPY: NOT REPORTED. CAUSALITY ASSESSMENT: PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) AND CATHETER CONTAMINATED: NOT REPORTED. FOLLOW UP INFORMATION ((B)(6) 2013): THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) WAS CONTACTED ON (B)(6) 2013 IN ORDER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE HOME PATIENT¿S (HP) PERITONITIS. THE PDRN STATED THAT THEY BELIEVE THE CAUSE OF THE PERITONITIS IS TOUCH CONTAMINATION BUT "CAN ONLY ASSUME". THE PDRN STATED THAT THE DEVICE, DISPOSABLES, AND DRUGS ARE NOT RELATED TO THE EVENT. SHE COULD NOT ANSWER ANYMORE QUESTIONS BECAUSE SHE WAS WITH A PATIENT AND HAD TO GO. A SEARCH OF (B)(4) FOR SUSPECT PRODUCTS SHIPPED WITHIN TWO MONTHS BEFORE THE INCIDENT SHOWED THE FOLLOWING: PRODUCT CODE R5C4479C, LOT NUMBER H13H12110, H13I01038, H13I30102.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677174 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization HOMECHOICE, MINICAP, EXTENSION SET, TRANSFER SET,| EXTRANEAL, DIANEAL LOW CALCIUM 1.5% AND 2.5%