BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1880614 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04839
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (GD874859, GD874842, AND GD876482) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING A CALL FOR AN UNRELATED ALARM, THE PATIENT INDICATED HE HAD PERITONITIS. FOLLOW-UP INFORMATION OBTAINED ON (B)(4) 2010 BY GLOBAL PHARMACOVIGILANCE IS AS FOLLOWS: ON (B)(6) 2006, THE PATIENT BEGAN PD THERAPY USING PD4 AMBUFLEX, INTRAPERITONEAL (IP). THE PATIENT'S MOST RECENT DOSE OF PD4 AMBUFLEX WAS 10.5 LITERS NIGHTLY. ON (B)(6) 2010, THE PATIENT DEVELOPED AN EXIT SITE INFECTION. CULTURE RESULTS REVEALED A YEAST INFECTION. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH FLUCONAZOLE FOR 3 WEEKS. THE EVENT OF EXIT SITE INFECTION WAS CONSIDERED RESOLVED AFTER FLUCONAZOLE THERAPY WAS COMPLETED. THE EVENT OF EXIT SITE INFECTION WAS NOT RELATED TO THE DIANEAL SOLUTION OR HOMECHOICE MACHINE. THE REPORTER DID NOT PROVIDE HER OPINION AS TO HOW THE PATIENT DEVELOPED THE EXIT SITE INFECTION. THE PATIENT REMAINED ON PD THERAPY. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. ON (B)(6) 2010, CULTURE RESULTS REVEALED STAPHYLOCOCCUS COAGULASE NEGATIVE. THE PATIENT WAS TREATED WITH IP ANTIBIOTICS. WHILE HOSPITALIZED THE PATIENT DEVELOPED TRANSIT ISCHEMIC ATTACKS (TIA) AND THE PATIENT WAS THOUGHT TO OF HAD A STROKE. WHEN ASKED IF THE REPORTER COULD PROVIDE SYMPTOMS THE PATIENT EXPERIENCED THE NURSE REPLIED, "SLUGGISH, NOT THINKING CLEARLY AND DELAYED RESPONSE." ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2010, THE PATIENT HAD HIS TRANSFER SET REPLACED. AT THE TIME OF THIS REPORT THE EVENT OF PERITONITIS AND TIA WITH POSSIBLE STROKE WAS CONSIDERED ONGOING AND IMPROVED. THE NURSE STATED THE EVENT OF PERITONITIS AND TIA WITH POSSIBLE STROKE WAS NOT RELATED TO THE DIANEAL SOLUTIONS, TRANSFER SET OR HOMECHOICE MACHINE. THE PATIENT REMAINED ON PD THERAPY, DOSE NOT CHANGED. THE NURSE STATED THERE WAS NO RELATION OF THE SEPTEMBER PERITONITIS AND AUGUST EXIT SITE INFECTION. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RISE IN SHOCK LEAD IMPEDANCE HAD INCREASED ALTHOUGH WAS STILL IN NORMAL LIMITS. THE ASSOCIATED PATIENT HAD INDICATED IN A CONVERSATION WITH THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT THAT THE LEAD WAS BROKE AND WAS GOING TO BE REPLACED. THE LOCAL AREA SALES REPRESENTATIVE STATED THAT A CHEST X-RAY HAD NOT YET BEEN DONE AND THAT TO DATE, THERE WAS NO EVIDENCE OF LEAD FRACTURE OR OTHER PRODUCT PERFORMANCE ANOMALY.

    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 46 YR Hospitalization| R PD4 AMBUFLEX