BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1884243 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04978
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. SHOULD A SAMPLE BE RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE FIRST OF THREE COMPLAINTS FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). IN REVIEW OF THE COMPLAINT IT WAS DETERMINED THAT THIS IS A REPORTABLE MALFUNCTION EVENT AND NOT A SERIOUS INJURY. THE MASTER COMPLAINT FOR THE EVENT OF PERITONITIS HAS BEEN REPORTED UNDER MANUFACTURER REPORT NUMBER: 1423500-2010-05308.

    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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER?S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR 2240 ALARM ON THE HOMECHOICE DEVICE. THE PATIENT DISCONNECTED DURING DWELL 4/4 AND FORGOT TO PRESS STOP. THE HP DID RECONNECT. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED WITH RETRIEVING THE SET AND ADVISED THE HP TO CALL THE NURSE. THIS COMPLAINT WILL ADDRESS THE EVENT OF THE 2240 ALARM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR 2240 ALARM ON THE HOMECHOICE DEVICE. THE PATIENT DISCONNECTED DURING DWELL 4/4 AND FORGOT TO PRESS STOP. THE HP DID RECONNECT. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED WITH RETRIEVING THE SET AND ADVISED THE HP TO CALL THE NURSE. DURING A FOLLOW UP CALL ON (B)(6) 2010, THE WIFE STATED THE NURSE WAS INFORMED OF THE INCIDENT. A TEST (UNKNOWN) WAS PERFORMED ON HER HUSBAND AND HE WAS PLACED ON ANTIBIOTICS (UNKNOWN) FOR A "BUG." THE WIFE STATED THAT IT WAS PERITONITIS. THE WIFE ALSO INDICATED THAT HER HUSBAND IS CURRENTLY IN THE HOSPITAL FOR LOW BLOOD PRESSURE AND GOUT. DURING A FOLLOW UP CALL ON (B)(6) 2010, THE FACILITY NURSE PROVIDED THE FOLLOWING INFORMATION: THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2010. THE EFFLUENT WAS CULTURED AND RETURNED POSITIVE FOR STAPHYLOCOCCUS AUREUS. A GRAM STAIN WAS PERFORMED AND RETURNED POSITIVE FOR GRAM POSITIVE COCCI. THE CELL COUNT WAS PERFORMED HOWEVER THE RESULTS ARE UNKNOWN. THE PATIENT DID NOT HAVE AN EXIT SITE OR TUNNEL INFECTION. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT OF PERITONITIS. THE PATIENT WAS PLACED ON CIPRO 500MG BID (TWO TIMES PER DAY) ORALLY UNTIL THE CULTURE RESULTS WERE RECEIVED THEN THE CIPRO WAS DISCONTINUED AND THE PATIENT WAS TREATED WITH VANCOMYCIN 2G INTRAPERITONEAL (IP) ON (B)(6) 2010 AND 1500MG IP ON (B)(6) 2010. THE CAUSE OF THE PERITONITIS WAS DETERMINED TO BE THAT THE PATIENT FAILED TO WEAR A MASK WHEN DISCONNECTING FROM THERAPY. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. THE PERITONITIS WAS CONSIDERED TO BE RESOLVED. THE NURSE INDICATED THAT THE PERITONITIS WAS NOT DUE TO USE OF BAXTER SOLUTIONS OR PRODUCTS. THIS IS THE MASTER COMPLAINT FOR THE EVENT OF PERITONITIS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE AUTO-ON STARTED TO FIRE IMMEDIATELY. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE LOT NUMBER IS UNK. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 5B9766 DIANEAL LOW CAL, ULTRA BAG DEXTROSE 1.50%..