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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET BALLOON PUMP CARDIOSAVE

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MAQUET BALLOON PUMP CARDIOSAVE Back to Search Results
Model Number 0998-00-0800-53
Device Problems Contamination (1120); Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 03/07/2021
Event Type  Death  
Event Description
Blood was noted to be collecting in tubing connected to pt and iabp device. Balloon serial number was (b)(4).
 
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Brand NameBALLOON PUMP
Type of DeviceCARDIOSAVE
Manufacturer (Section D)
MAQUET
drive wayne NJ 07470
MDR Report Key11626945
MDR Text Key244273078
Report Number11626945
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/18/2021
Device Age6 YR
Event Location Hospital
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/19/2021 Patient Sequence Number: 1
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