BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2961886 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03773
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EPISODE OF RECURRENT PERITONITIS OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2013. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 11 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBER GD893859 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. THIS COMPLAINT FOR PERITONITIS IS NOT CONFIRMED BECAUSE NO SAMPLES WERE RETURNED TO BAXTER, REVIEWS OF MANUFACTURING RECORDS REVEALED NO ISSUES, AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. A CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A NURSE OF A PATIENT WITH PERITONITIS. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS AND DISCHARGED AT A LATER DATE. THE PATIENT HAD JUST RECENTLY FINISHED THE LAST ROUND OF UNSPECIFIED ANTIBIOTICS FROM THE LAST EPISODE OF PERITONITIS AND THE PATIENT STILL HAD ISSUES WITH PERITONITIS RETURNING. FOLLOW UP INFORMATION WAS RECEIVED FROM A NURSE. THE NURSE REPORTED THAT THE PATIENT HAS EXPERIENCED MULTIPLE CASES OF RECURRENT PERITONITIS. THE CAUSATIVE AGENT FOR ALL EPISODES WAS COAGULASE NEGATIVE STAPHYLOCOCCUS EPIDERMIDIS. FOR EVERY EPISODE OF RECURRENT PERITONITIS, THE PATIENT WAS TREATED WITH VANCOMYCIN AND GENTAMYCIN, INTRA-PERITONEALLY (DOSES AND FREQUENCIES UNKNOWN). THE NURSE STATED THAT AFTER RECOVERING FROM EACH EPISODE OF PERITONITIS, THE PATIENT WOULD GET PERITONITIS AGAIN WITHIN A FEW WEEKS OF THE PREVIOUS EPISODE. THE NURSE REPORTED THAT THE PATIENT WAS RE-CULTURED AFTER EACH EVENT OF PERITONITIS TO MAKE THE DETERMINATION THAT HE HAD RECOVERED FROM EACH EVENT. THE RESULTS OF THE CULTURES HAD SHOWN NO GROWTH. THE NURSE STATED THAT THE CAUSE OF THE RECURRENT PERITONITIS IS UNKNOWN. THE PATIENT DENIES ANY BREAK IN ASEPTIC TECHNIQUE BUT THE PATIENT WAS RETRAINED IN PROPER ASEPTIC TECHNIQUE AFTER EACH EPISODE OF RECURRENT PERITONITIS. THE PATIENT HAS RECOVERED FROM THIS EVENT OF PERITONITIS. PERITONEAL DIALYSIS THERAPY WAS ONGOING AND, PER THE NURSE, THE RECURRENT PERITONITIS IS NOT RELATED TO BAXTER'S DIANEAL SOLUTION, DEVICE, OR DISPOSABLE PARTS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. SAME PATIENT AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64788 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX (2.5%)