BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2063170 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04707
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW FOR POTENTIALLY ASSOCIATED LOT 10J15H25 WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 4 FOR THIS INCIDENCE OF PERITONITIS. AS PATIENT DISCARDS SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BAXTER CONTACTED THE PATIENT'S PERITONEAL DIALYSIS (PD) RN ON (B)(4) 2011 TO FOLLOW UP ON THE PERITONITIS REPORTED BY A CAREGIVER IN AN UNRELATED ALARM COMPLAINT. THE PD RN REPORTED THAT ON (B)(6) 2011, THE PATIENT WAS NOT FEELING WELL AND HAD A FEVER. THE PATIENT'S WIFE CALLED THE AMBULANCE AND HE WAS ADMITTED TO THE HOSPITAL ON THAT DAY. SHE CONFIRMED THAT THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND ALSO HAD SOME CARDIAC ISSUES ON ADMISSION TO THE HOSPITAL. SHE HAD NO INFORMATION ON THE ADMITTING DIAGNOSIS RELATED TO THE CARDIAC ISSUE. SHE REPORTED THE PATIENT'S DIAGNOSIS WAS NOT AGGRAVATED BY ANY PD SOLUTIONS OR DEVICES AS THE PATIENT WAS NOT RECEIVING PD THERAPY AT THE TIME OF THE INCIDENT. PD EFFLUENT CULTURES WERE DONE ON AN UNKNOWN DATE.. SHE DID NOT KNOW IF GRAM STAIN OR WBC WAS DONE. SHE REPORTED THE PATIENT WAS BEING TREATED WITH TOBRAMYCIN UNKNOWN DOSE AND LENGTH OF TREATMENT) INTRAPERITONEALLY (IP). THE PATIENT HAD NO EXIT SITE INFECTION. THE PATIENT REMAINS HOSPITALIZED. THE PD CATHETER WILL BE REMOVED AND PD THERAPY WILL BE PLACED ON HOLD. THE PATIENT WILL START INTER-CENTER HEMODIALYSIS (ON AN UNKNOWN DATE) AND REMAIN ON THIS THERAPY UNTIL THE PERITONITIS HAS RESOLVED. NO FURTHER INFORMATION WAS AVAILABLE.

    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 81 YR Hospitalization| R HOMECHOICE| LOCAL (PD4) AMBUFLEX