BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2080068 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05569
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER 10J15H25 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM A CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION FROM A NURSE FROM THE USA OF LOOSE TUBING NOT PROPERLY IN PLACE AND PERITONITIS 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 TO BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON AN UNREPORTED DATE IN 2011, THE PATIENT EXPERIENCED LOOSE TUBING NOT PROPERLY IN PLACE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. OUTCOME FOR THE EVENT OF LOOSE TUBING NOT PROPERLY IN PLACE WAS NOT REPORTED. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN AND THE PATIENT WAS PLACED ON HEMODIALYSIS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY. ON (B)(6) 2011, FOLLOW UP INFORMATION WAS RECEIVED FROM THE PD NURSE (PDN). THE PDN STATED THE PATIENT WAS TREATED FOR THE PERITONITIS HOWEVER, DID NOT HAVE THE TREATMENT INFORMATION. THE PDN WAS NOT AWARE OF ANY LOOSE TUBING AND DID NOT BELIEVE THE PERITONITIS WAS DUE TO A PRODUCT PROBLEM. THE PDN CHANGED THE PATIENT'S TRANSFER SET ON (B)(6) 2011 (DESCRIBED AS "BAXTER TWIST, BLUE AND WHITE"). THE PDN REPORTED THAT THE PATIENT RECENTLY MOVED FROM (B)(6) AREA TO (B)(6) WHERE THE RESIDENTS WERE INSTRUCTED NOT TO USE THE WATER SUPPLY. THE PDN DID NOT HAVE FURTHER SPECIFICS BUT FEELS THAT THE CASE OF PERITONITIS WAS SOMEHOW ONGOING FROM (B)(6) AND RELATED TO THE WATER SUPPLY SITUATION IN THE AREA THE PATIENT WAS LIVING AND THOUGHT THAT MAYBE THE PATIENT'S CATHETER WAS COLONIZED WITH BACTERIA. THE PATIENT WAS TAKEN OFF OF PD AND IS NOW ON HEMODIALYSIS AND IS NOT CURRENTLY A PATIENT OF THEIR CLINIC. THE PDN STATED THE PATIENT RECOVERED FROM THE PERITONITIS EVENT, HOWEVER, REMAINS ON HEMODIALYSIS AT THIS TIME. SHE DID NOT KNOW IF THE PATIENT WOULD BE RETURNING TO PD IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX