BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2222619 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11223
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN THEREFORE NO EVALUATION OR BATCH REVIEW WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS SEEN AT THE HOSPITAL IN (B)(4) 2011 DUE TO A STROKE. HE WAS TRANSFERRED TO A REHAB FACILITY THEN DISCHARGED TO HOME ON AN UNKNOWN DATE. A FEW DAYS LATER THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT WAS DIAGNOSED WITH PERITONITIS (B)(6) 2011. HE WAS NOT HOSPITALIZED FOR THIS EVENT. THERE WAS NO EXIT SITE INFECTION ASSOCIATED WITH THIS EVENT. THE PATIENT WAS TREATED WITH CEFAZOLIN INTRAPERITONEAL (IP). REPORTEDLY THE BAXTER SOLUTIONS AND DEVICES WERE NOT CONSIDERED SUSPECT. THE PATIENT REPORTEDLY HAS POOR ASEPTIC TECHNIQUE, THERE WAS TOUCH CONTAMINATION AND HE DOES NOT WEAR A MASK. THE PATIENT HAS BEEN RETRAINED. THE PATIENT IS NON-COMPLIANT AND BECOMES CONFUSED. THE PATIENT RECOVERED FROM THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS (11C23H25) 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. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH CAPA (B)(4).

    Description of Event or Problem · 1

    THE NURSE CONTACTED THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) TO ADVISE THE MALE PATIENT EXPERIENCED PERITONITIS AND WOULD BE GOING TO A REHAB FACILITY FOR THERAPY. THE NURSE ADDITIONALLY REPORTED THAT THE PATIENT DID NOT RECEIVE THE CORRECT SOLUTION. THE NURSE WAS INSTRUCTED TO CONTACT THE FACILITY NURSE FOR TRAINING AND REGARDING THE SOLUTION PART OF THE PRESCRIPTION. THE PATIENT OUTCOME IS UNKNOWN. REPEATED ATTEMPTS TO REACH THE PROFESSIONAL CONTACTS HAVE NOT BEEN SUCCESSFUL.

    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 82 YR Required Intervention (B)(4) LO/CAL UB (B)(4) DN| (B)(4) LO/CAL (B)(4) DIANEAL| (B)(4) LO/CAL UB (B)(4) DN| (B)(4) LO/CAL (B)(4) DIANEAL| (B)(4) LO/CAL (B)(4) DIANEAL| (B)(4) LO/CAL UB (B)(4) DN| HOMECHOICE