BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE

    MDR report key: 2771367 · Received August 27, 2012

    Report

    Report Number
    2771367
    Event Type
    Malfunction
    Date Received
    August 27, 2012
    Date of Event
    January 24, 2012
    Report Date
    August 27, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    IABP ALARMED: BLOOD DETECTED. THERE WAS NO OBVIOUS BLOOD IN TUBING NOTED. PUMP OFF AND CICU FELLOW CAME IN TO IMMEDIATELY PULL PUMP. PT ON IV HEPARIN. CURRENTLY HAVING CHEST PAIN ON AND OFF ALL MORNING WITH NITRO GTT. THE DOCTOR WAS NOTIFIED. IABP CATHETER REMOVED AT APPROXIMATELY 18 MINUTES. MANUAL PRESSURE APPLIED X 1 HOUR AND 20 MINUTES. SITE GOOD, NO HEMATOMA. THE PLAN WAS TO LEAVE PUMP IN FOR AN ADDITIONAL DAY DUE TO CHEST PAIN. IABP CATHETER KEPT AND UPON VISUAL INSPECTION DID NOTE A SMALL SPOT THAT LOOKED IRREGULAR NEAR THE TIP OF THE BALLOON. DATASCOPE CALLED AND NOTIFIED VIA DISPATCH. MAY TAKE PT BACK TO CATH LAB TO REPLACE IABP IF CHEST PAIN RETURNS. THIS WAS A MINOR INJURY WITH ONLY MONITORING REQUIRED. CLINICAL ENGINEERING (CE) PICKED UP IABP CATHETER FROM MANAGER'S OFFICE. WILL RETURN TO MANUFACTURER FOR ANALYSIS. CE ASKED BIOMED TO CHECK OUT THE PUMP AS A PRECAUTION. BIOMED EVALUATED PUMP. PUMP NEEDED A REPLACEMENT PART WHICH MAY HAVE CAUSED THE BLOOD DETECTED ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE SYSTEM, BALLOON, INTRA-AORTIC DSP MAQUET CARDIOVASCULAR, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR