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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 06/06/2020
Event Type  Death  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. A company representative has confirmed that the customer has not alleged any malfunction/failure of the iabp unit and that no repairs will be carried out on the unit. Additionally, it has also been confirmed that the unit is functioning well. No further investigation is required. Full event site name: (b)(6) memorial hospital.
 
Event Description
It was reported that during cs300 intra-aortic balloon pump (iabp) therapy, blood was seen in the catheter tubing (gas line) while insertion in to the right femoral artery , the intra-aortic balloon catheter (iabc) was retracted and was replaced with new iabc and the therapy was started. The patient later expired, but details of the patient's death was not provided to us. There was no reported malfunction of the iabp, and it is unknown if the facility is attributing the patient's death to the iabp. A separate report will be submitted for the involved iabc.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10201420
MDR Text Key196613709
Report Number2249723-2020-00985
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/05/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/26/2020 Patient Sequence Number: 1
Treatment
LINEAR IAB 40CC
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