BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1910009 · Received November 30, 2010

    Report

    Report Number
    1423500-2010-06359
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED; THEREFORE, NO EVALUATION WAS PERFORMED. SHOULD A SAMPLE BE RETURNED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE SECOND OF FOUR REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT CALLED THE BAXTER TECHNICAL SERVICES REPRESENTATIVE (TSR) TO DISCONTINUE USE AND RETURN THE HOMECHOICE DEVICE FOR AN UNKNOWN REASON. DURING A FOLLOW UP CALL ON (B)(6) 2010, THE FACILITY NURSE INDICATED PATIENT WAS HAVING THE PERITONEAL DIALYSIS CATHETER REMOVED DUE TO THE PERITONITIS. THE PATIENT WAS PLACED ON HEMODIALYSIS. ON 18NOV 2010, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE NURSE. AT THE TIME OF DIAGNOSIS, THE PATIENT WAS USING AMBULATORY PERITONEAL DIALYSIS (APD) WITH LOCAL (PD4) AMBUFLEX ON THE HOMECHOICE. THE PATIENT REPORTEDLY FOUND A HOLE IN HER PERITONEAL DIALYSIS (PD) CATHETER, BUT DID NOT CALL THE CLINIC. THE PATIENT REPORTEDLY TAPED THE HOLE AND CONTINUED TO USE THE CATHETER. THE NURSE HEARD FROM THE PATIENT ON (B)(6) 2010. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010, DUE TO PERITONITIS. THE PD EFFLUENT WAS CULTURED BEFORE THE INITIATION OF ANTIBIOTIC THERAPY WITH A RESULT OF NO ORGANISM GROWTH. THE CELL COUNT RESULTS AND OTHER TESTS RESULTS ARE NOT AVAILABLE. THE PERITONITIS WAS TREATED WITH DAILY INTRAVENOUS (IV) VANCOMYCIN (DOSE UNKNOWN), WHICH CONTINUED AFTER DISCHARGE. THE NURSE STATED THAT THE PATIENT WAS NONCOMPLIANT WITH THE OUTPATIENT ANTIBIOTIC THERAPY RECEIVED AT THE PD CLINIC AND MISSED DOSES. THE PATIENT HAS RECOVERED AND HAS BEEN RECEIVING HEMODIALYSIS SINCE THE PERITONITIS DIAGNOSIS. SHE PLANS TO RETURN TO PD THERAPY AS SOON AS PLACEMENT OF ANOTHER PD CATHETER IS SCHEDULED. THE SUSPECT CATHETER WAS A DOUBLE CUFF FROM AN UNKNOWN MANUFACTURER. THE NURSE DID NOT KNOW ITS MANUFACTURER, BUT IS SURE THE SURGEON USES PRODUCTS FROM A COMPANY OTHER THAN BAXTER. THE PATIENT HAS HAD A HISTORY OF NONCOMPLIANCE WITH TESTS AND APPOINTMENTS AT THE CLINIC. IT IS UNKNOWN WHETHER THE PATIENT PERFORMED HER PD THERAPY AS PRESCRIBED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT TITLED "COMPARISON OF CLINICAL EFFECT BETWEEN PVP AND PKP FOR TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", THAT: 30 PATIENTS UNDERWENT OPERATIONS WITH PVP (PERCUTANEOUS VERTEBROPLASTY) AND 45 UNDERWENT OPERATIONS WITH PKP (PERCUTANEOUS KYPHOPLASTY). THE OPERATIONS WERE SUCCESSFUL IN ALL PATIENTS. IN 16 CASES OF PVP AND 11 CASES OF PKP, CEMENT LEAKAGE OCCURRED; HOWEVER, WITHOUT CLINICAL SYMPTOMS. NO FURTHER INFORMATION WAS REPORTED. IT IS UNKNOWN IF THE BONE CEMENT USED WAS HV-R. NOTE: MEDTRONIC SPINE, LLC DOES NOT CURRENTLY DISTRIBUTE PRODUCT IN CHINA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R LOCAL (PD4) AMBUFLEX