BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITROGLYCERIN, MID-LENGTH SECONDARY IV PUMP SET

    MDR report key: 164651 · Received April 23, 1998

    Report

    Report Number
    MW1013642
    Event Type
    Malfunction
    Date Received
    April 23, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PROBLEM: PRODUCT PROBLEM POOR PACKAGING OR LABELING. DESCRIPTION: THE ABBOTT LABS #11140 LATEX-FREE, NITROGLYCERIN, MID-LENGTH SECONDARY IV PUMP SET PACKAGE IS LABELED. ORIGINALLY, AN IDENTIFYING BLUE KNARLED ROLLER-CLAMP KNOB WAS INCORPORATED INTO THE SET. IN THE RE-DESIGNED #11140, THE BLUE KNARLED ROLLER-CLAMP KNOB IS NOW WHITE. ONCE REMOVED FROM THE PACKAGE, IT IS INDISTINGUISHABLE FROM ABBOTT LABS #1139 LATEX-FREE, MID-LENGTH SECONDARY IV SET, ITS POLY VINYL CHLORIDE COUNTERPART. INADVERTENT USE OF A POLY VINYL CHLORIDE SET WILL NOW BE IMPOSSIBLE TO DETECT. BACKGROUND: NITROGLYCERIN IS USED FOR CARDIO-VASCULAR SUPPORT IN EMERGENCY SITUATIONS. SEVERAL YRS AGO, IT WAS NOTED THAT NITROGLYCERIN WAS ABSORBED BY POLY VINYL CHLORIDE CONTAINERS AND IV SETS RENDERING IT DIFFICULT TO ACCURATELY AND CONSISTENTLY TITRATE THE MEDICATION. SEVERAL OTHER DRUGS EXHIBIT SIMILAR ADSORPTION PROBLEMS. THE MFRS OF TWO CHEMOTHERAPY PRODUCTS USED AT THIS FACILITY, PACLITAXEL (TAXOL) AND DOECTAXEL (TAXOTERE), RECOMMEND THE USE OF NON-POLY VINYL CHLORIDE CONTAINERS AND IV SETS. IT IS IMPORTANT HEALTH CARE PROFESSIONALS ADMINISTERING THESE MEDICATIONS TO BE ABLE TO READILY IDENTIFY THE EQUIPMENT, SUPPLIES, AND MEDICATIONS THEY ARE USING. REMOVING IDENTIFYING FEATURES (EG BLUE KNARLED ROLLER-CLAMP KNOB) FROM SPECIALTY IV SETS MAY LEAD TO MEDICATION ADMINISTRATION ERRORS. ABBOTT LABS REP, HAS INVESTIGATED THIS PROBLEM AND STATED THAT THE CO FEELS THAT THIS CHANGE IS AN INTERNAL MFG DECISION AND NOT A QA ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITROGLYCERIN, MID-LENGTH SECONDARY IV PUMP SET IV PUMP ST, NITROGLYCERIN, SECONDARY FPA ABBOTT LABORATORIES * *
    2 LATEX-FREE, NITROGLYCERIN, MID-LENGTH SECONDARY IV PUMP SET IV PUMP SET, NITROGLYCERIN, SECONDARY FPA ABBOTT LABORATORIES * *
    3 LATEX-FREE, MID-LENGTH SECONDARY IV SET IV PUMP SET, NITROGLYCERIN, SECONDARY FPA ABBOTT LABORATORIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *