BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE DISPOSABLE TRANSPAC IV TRANSDUCER

    MDR report key: 151825 · Received February 20, 1998

    Report

    Report Number
    1713468-1998-00015
    Event Type
    Malfunction
    Date Received
    February 20, 1998
    Date of Event
    January 1, 1998
    Report Date
    January 20, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DRS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    9 USED SAMPLES RECEIVED FOR ANALYSIS. RESULTS OF VISUAL EXAM AS FOLLOWS: UNIT #1-NOTE STATES PRODUCT FAILED 10/5/97. SQUEEZE FLUSH DEVICE (SFD) CRACKED ON DISTAL FEMALE CONNECTOR; MATING PART TO CONNECT KIT TO PUMP NOT RECEIVED. UNIT 2-NON-CONFORMANCE NOT CONFIRMED. KIT FUNCTIONALLY AND VISUALLY INSPECTED FOR LEAKS AND/OR CRACKS; NONE PRESENT. UNIT #3-NOTE STATES PRODUCT FAILED 9/28/97. ONLY SFD RECEIVED. CRACKING NOTED ON MOLDING KNIT LINE OF DISTAL FEMALE CONNECTOR; DEEP MARKS INDICATING POSSIBLE USE OF HEMOSTATS; MATING PART NOT RECEIVED. UNIT #4-SFD ONLY RECEIVED. CRACKS NOTED ON FEMALE CONNECTOR; MATING PART NOT RECEIVED. UNIT #5-SFD WAS CRACKED ON THE DISTAL FEMALE CONNECTOR; SEVERAL CRACKS ON SFD FEMALE CONNECTOR AT IV CONNECTION. UNITS #6 & #7-KITS DESPLAYED CRACKS ON DISTAL SFD FEMALE CONNECTORS; MATING PARTS NOT RECEIVED. UNIT #8-KIT DISPLAYED CRACKS ON DISTAL SFD FEMALE CONNECTOR; MATING PART NOT RECEIVED; MULTIPLE CRACKS OBSERVED. UNIT #9-KIT DISPLAYED CRACKS ON DISTAL SFD FEMALE CONNECTOR; MATING PART NOT RECEIVED. NON-ABBOTT PARTS RECEIVED WITH KIT. AN AUDIT WAS PERFORMED ON THE WORK ORDERS ASSOCIATED WITH THE MANUFACTURE OF THE PRODUCT. NO NON-CONFORMING CONDITIONS WERE FOUND THAT WOULD CAUSE THIS PROBLEM. INVESTIGATION OF THE RAW MATERIAL RECEIVED FROM THE VENDOR REVEALED IT TO BE WITHIN ACCEPTABLE MATERIAL SPECIFCATION RANGES. ADDITIONAL TESTING PERFORMED EVALUATED THE EFFECTS OF EXPOSURE OF THE SFD POLYCARBONATE COMPONENT TO CERTAIN LIQUIDS. CRACKING AND/OR LEAKAGE AT THE SFD FEMALE CONNECTOR WAS RECREATED ONLY WHEN THE SFD FEMALE CONNECTOR HAD EXPOSED TO LIPIDS AND 70% ISOPROPYL ALCOHOL, WAS ATTACHED TO A MALE ADAPTER, AND LIPIDS ALLOWED TO RUN THROUGH THE FLUID LINE. CONNECTIONS MADE WITH DRY CONNECTORS OR CONNECTORS EXPOSED TO EITHER LIPIDS OR 70% ALCOHOL ONLY DID NOT CRACK OR LEAK. SFD POLYCARBONATE COMPONENT IS THE ONLY COMPONENT EXHIBITING CRACKING. THIS IS LIKELY DUE TO THE LIPIDS PROVIDING STRESS RELIEF FOR THE MOST HIGHLY STRESSED COMPONENT.

    Description of Event or Problem · 1

    RECEIVED GENERAL REPORT OF UNDOCUMENTED INCIDENCES OF CRACKING AND LEAKING PORTS OF TRANSDUCER LINES DURING USE WITH ADMINISTRATION OF LIPID SOLUTION. DURING THE USE OF A MONITORING LINE TO AN UMBILICAL ARTERY SITE IN NICU, NURSES NOTED THE CRACKING AND LEAKING OF A PORT DURING INFUSION OF LIPIDS. THE LIPIDS WERE BEING ADMINISTERED AT THE RATE OF 1CC/HR, ALONG WITH OTHER UNSPECIFIED FLUIDS AT AN UNSPECIFIED RATE, AND LEAKAGE OF IV FLUID OCCURRED. BLEEDBACK WAS NOTED IN THE LINE, NO BLOOD LOSS REPORTED. NOTED BY THE NURSE AT THE BEDSIDE IMMEDIATELY. CHANGED SET TO SOLVE PROBLEM. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE DISPOSABLE TRANSPAC IV TRANSDUCER PRESSURE MONITORING KIT DRS ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other