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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0295-02
Device Problems Filling Problem (1233); Leak/Splash (1354); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  malfunction  
Manufacturer Narrative
Occupation: respiratory therapist. The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed. Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the patient had gotten up and the console began indicating that it was unable to fill and displayed negative numbers. Upon further inspection of the tubing, blood was seen in the helium line. The console was placed in standby mode and the respiratory therapist (rt) was called. The rt was able to clamp the tubing prior to the blood ever reaching the console. The iab was removed and a new iab was placed without issue. Approximately one day later, the second iab was removed after the patient received biventricular assist device (bivad) placement. There was no patient harm or adverse event reported.
 
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Brand NameMEGA 7.5FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 
MDR Report Key11982411
MDR Text Key255643236
Report Number2248146-2021-00368
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120868
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0295-02
Device Catalogue Number0684-00-0293
Device Lot Number3000132559
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/11/2021 Patient Sequence Number: 1
Treatment
AUTOCAT2WAVE CONSOLE/BIVENTRICULAR ASSIST DEVICE.
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