BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2071669 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05127
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 1OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H11B07081 AND H11A04023 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A FOLLOW UP CALL TO THE PERITONEAL DIALYSIS (PD) RN TO FOLLOW UP ON RECURRENT CASES OF PERITONITIS (REPORTED SEPARATELY) ADDITIONAL INFORMATION WAS OBTAINED PERTAINING TO THIS CASE OF PERITONITIS. THE PDN VERBALIZED THAT THE PATIENT EITHER TOUCHED THE TRANSFER SET OR PATIENT LINE ON THE TUBING ON THE CASSETTE. ON AN UNREPORTED DATE IN MARCH THE PATIENT WAS TREATED WITH VANCOMYCIN (UNKNOWN DOSE) INTRAPERITONEALLY (IP), ANCEF IP AND BACTRIM PO FOR AN UNSPECIFIED AMOUNT OF TIME.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS WITH (B)(6) AND (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY. IN (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX (LOT NUMBER, DOSAGE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THE FOLLOWING. ON AN UNKNOWN DATE THE PATIENT EXPERIENCED A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED AND HOSPITALIZED FOR PERITONITIS. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND DISCHARGED FROM THE HOSPITAL. DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION.

    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 57 YR Hospitalization DIANEAL PD2 AMBUFLEX