BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2060715 · Received April 18, 2011

    Report

    Report Number
    1423500-2011-04618
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS H11A25028 AND H10L04022 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS REPORT BY A NURSE IN (B)(6) OF TOUCH CONTAMINATION/PATIENT MADE A MISTAKE/PATIENT DID NOT WEAR A MASK AND PERITONITIS WITH CULTURE (B)(6) FOR CANDIDA IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE, RESULTING IN A TOUCH CONTAMINATION AND DID NOT WEAR A MASK WHILE PERFORMING THERAPEUTIC PD. TREATMENT AND OUTCOME FOR THE EVENT OF TOUCH CONTAMINATION/PATIENT MADE A MISTAKE/PATIENT DID NOT WEAR A MASK WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, AND WAS HOSPITALIZED ON THE SAME DAY. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. THE NURSE REPORTED THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF TOUCH CONTAMINATION/PATIENT MADE A MISTAKE/PATIENT DID NOT WEAR A MASK; HOWEVER, THE NURSE REPORTED THE PERITONITIS WAS CAUSED BY THE TOUCH CONTAMINATION/PATIENT MADE A MISTAKE/PATIENT DID NOT WEAR A MASK. THE NURSE REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD HIS PD CATHETER REMOVED AND WAS STARTED ON HEMODIALYSIS. THE NURSE REPORTED THE RECOVERY STATUS AS UNKNOWN. THE NURSE DECLINED TO PROVIDE FURTHER 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 48 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE