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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 0998-00-0800-33
Device Problem Failure to Sense (1559)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/03/2021
Event Type  Death  
Manufacturer Narrative
Communication/interviews : a getinge field service engineer (fse) advised that the end user check the inner lumen for any obstruction or clot, and if they would be able to aspirate blood. The end user indicated everything seemed to be ok. The fse then advised the end user to replace the transducer. When the end user was replacing the transducer, it was observed that the end user had forgotten to open the 3-way stop cock at the patient end which had resulted in the reported issue. Once the 3-way stop cock was opened and the iabp unit was zeroed, it was observed to be working properly. The fse has indicated that the event was caused due to user error. Testing of actual/suspected device : the fse arrived at the customer's site at a later date and all functional and safety checks were performed and found to be working to factory specifications. The iabp was then cleared for clinical use and returned to the customer. A supplemental report will be submitted upon completion of our investigation. The full name of the event site was shortened due to field character limit; the full name is (b)(6) hospital.
 
Event Description
It was reported that during use on a patient the cardiosave intra-aortic balloon pump (iabp) was not showing the correct pressures. No patient harm, serious injury or adverse event was reported. It was later reported on (b)(6) 2021 that the patient had expired on (b)(6) 2021. The customer has not attributed the patient's death to the device.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12380058
MDR Text Key268559066
Report Number2249723-2021-01936
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-33
Device Catalogue Number0998-00-0800-33
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2021
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/27/2021 Patient Sequence Number: 1
Treatment
LINEAR 7.5 FRENCH 40CC
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