BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1841741 · Received September 22, 2010

    Report

    Report Number
    1423500-2010-03625
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. LOT INFORMATION IS UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240. THE REPORT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. THE RN STATED THE SUPPLY BAG FELL AND DISCONNECTED. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT INFORMATION WAS NOT KNOWN. 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 THROUGH (B)(4).

    Description of Event or Problem · 1

    A NURSE (RN) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 5 OF 6. THE RN STATED THE SUPPLY BAG FELL AND DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE RN TO CLEAR THE ERROR AND ADVISED THAT SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE RN CONFIRMED TO COMPLETE PATIENT THERAPY WITH A MANUAL BAG. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE RN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    FOUR FR SINGLE LUMEN GROSHONG WAS INSERTED AND WHEN THE PICC WAS FLUSHED WITH THE SALINE FROM THE KIT THE PT EXPERIENCED SHORTNESS OF BREATH, CHEST PAIN AND PANIC. WHEN SALINE WAS BEING FLUSHED, PT EXPERIENCED SHORTNESS OF BREATH, ANXIETY, AND "EYES ROLLED BACK." REACTION WAS TRANSIENT, SO THERE WAS NO NEED TO CALL A RAPID RESPONSE. NO VITAL SIGNS WERE TAKEN. REACTION BEGAN WHEN PICC WAS BEING FLUSHED, PRIOR TO DRESSING, PRIOR TO CLEANING THE SITE, AND AFTER STYLET WAS REMOVED. WHEN PLACEMENT WAS CHECKED, THE TIP OF THE CATHETER WAS "2 CM TOO FAR," AT THE ENTRANCE TO THE RIGHT ATRIUM. CATHETER WAS PULLED BACK 2 CM, AND PICC REMAINS IN THE PT. RN FLUSHES WITH "RAPID" SALINE FLUSH TO CLEAR THE LINE OF BLOOD AFTER CHECKING ASPIRATION.

    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 66 YR