BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTA MULTI-PATIENT DISPOSABLE SET

    MDR report key: 2630877 · Received June 21, 2012

    Report

    Report Number
    2520313-2012-00019
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 25, 2012
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM SERVICE CHECK OF THE AVANTA FLUID MANAGEMENT SYSTEM COMPLETED (B)(4) 2012 VERIFIED THE SYSTEM IS OPERATING WITHIN MEDRAD SPECIFICATIONS. THE SITE DISCARDED THE MEDRAD MULTI PATIENT DISPOSABLE SET (MPAT), THE SINGLE PATIENT DISPOSABLE SET (SPAT), AND THE SYRINGE; HOWEVER, THE SITE WAS ABLE TO PROVIDE THE LOT NUMBER OF THE SYRINGE IN USE AT THE TIME OF THE ALLEGED INCIDENT. A RETAINED DISPOSABLE FROM THE REPORTED LOT NUMBER WAS OBTAINED AND FUNCTIONALLY TESTED CONFIRMING THAT THE RETAINED DISPOSABLE PERFORMED TO SPECIFICATION WITH NO PROBLEMS OBSERVED. A SYRINGE PLUNGER DETACHMENT RESULTS IN AN INTERRUPTED PROCEDURE OR SYSTEM NOT AVAILABLE HAZARD. THE PISTON DETACHING FROM THE PLUNGER WILL NOT CAUSE AN AIR INJECTION. THE AVANTA OPERATION MANUAL STATES THAT THE OPERATOR IS REQUIRED TO EXPEL ALL TRAPPED AIR FROM THE SYRINGE, DRIP CHAMBERS, CONNECTORS, TUBINGS, AND CATHETER BEFORE CONNECTING TO THE PT. ON (B)(4) 2012 MEDRAD DISTRIBUTED A FIELD SAFETY NOTICED REINFORCING THE IMPORTANCE OF FOLLOWING THE MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM INSTRUCTIONS FOR USE. THE NOTICE FOCUSES ON ENSURING THE PT IS DISCONNECTED BEFORE PURGING THE MULTI-PATIENT DISPOSABLE SET (MPAT) OR SINGLE-PATIENT DISPOSABLE SET (SPAT) DISPOSABLES TO PREVENT AIR EMBOLISM. THE SITE SIGNED AND RETURNED THE CONFIRMATION PAGE OF THE NOTICE. THE SITE'S FAILURE TO DISCONNECT THE PT PRIOR TO PURGING THE NEW SYRINGE CAUSED THE REPORTED INCIDENT. THIS USE ERROR WAS RECOGNIZED BY THE SITE. ADD'L APPLICATIONS TRAINING WAS OFFERED TO THE SITE, BUT WAS DECLINED.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A PT WAS UNDERGOING CARDIAC CATHETERIZATION WHEN A PISTON PLUNGER DISENGAGEMENT OF THE SYRINGE OCCURRED. THE STAFF EXCHANGED THE SYRINGE AND PROCEEDED TO PURGE THE NEW SYRINGE WHILE CONNECTED TO THE PT CAUSING AN AIR INJECTION. THE PT THEN EXPERIENCED CARDIAC ARREST REQUIRING MEDICAL INTERVENTION WHICH INCLUDED CARDIOPULMONARY RESUSCITATION AND ADMISSION TO THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA MULTI-PATIENT DISPOSABLE SET ANGIOGRAPHIC TUBING SET DXT MEDRAD AVA 500 MPAT 118044

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R AVANTA SINGLE-PATIENT DISPOSABLE SET (SPAT)| AVANTA FLUID MANAGEMENT INJECTION SYSTEM