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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE US SALES LLC / DATASCOPE CORP. MAQUET-GETINGE BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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GETINGE US SALES LLC / DATASCOPE CORP. MAQUET-GETINGE BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number SENSATION PLUS 8F 50ML
Device Problems Deflation Problem (1149); Material Rupture (1546)
Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160)
Event Date 11/01/2020
Event Type  Injury  
Event Description
While pt was in the cvicu the pt turned in bed and blood was noted in the iabp (which was placed on (b)(6) 2020). The cath lab team was called in to remove the iabp under fluoroscopy. The interventional cardiologist was unable to remove the iabp end called vascular surgery. Vascular surgery took the patient to the or end did a cut down to remove the balloon. It was noted that the balloon was ruptured und did not deflate completely causing a tear in the femoral artery. The artery was patched successfully without complication. Plaque was noted in the artery.
 
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Brand NameMAQUET-GETINGE BALLOON PUMP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
GETINGE US SALES LLC / DATASCOPE CORP.
MDR Report Key10829328
MDR Text Key216186599
Report NumberMW5097803
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSENSATION PLUS 8F 50ML
Device Catalogue Number0684-00-0576
Device Lot Number300126212
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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