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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG 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 10/16/2020
Event Type  Death  
Manufacturer Narrative
A getinge service engineer evaluated the iabp unit and after trouble shooting and checking the unit for proper operation he was unable to reproduce the reported issue. No problems found. All calibrations and leak tests were within factory specs. The unit passed all functional and safety tests per factory specifications. Returned unit to the customer and cleared for clinical use.
 
Event Description
It was reported that during use on a patient, after 12 hours of use without issue prior to going in for surgery, the cardiosave intra-aortic balloon pump (iabp) was placed in semi auto mode, internal trigger, and 1 to 3 frequency during bypass. After the procedure lasting approximately 2. 5 hours, the iabp was placed back into auto mode and frequency placed to 1 to 1. The iabp alarmed "catheter restriction and fiber optic sensor failure". The catheter was replaced but therapy was not able to resume. The iabp was then replaced and therapy continued. It was reported that the patient expired later that same day. The customer does not attribute the patient's death to the iabp. This report is for the first iabp used. The replacement iabp and the two iab catheters used are being reported under separate medical device reports.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
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 Key10852038
MDR Text Key216611596
Report Number2249723-2020-01920
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
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
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/17/2020 Patient Sequence Number: 1
Treatment
2 SENSATION PLUS 50CC IAB CATHETERS
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