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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 0998-00-3023-53
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 04/04/2021
Event Type  Death  
Manufacturer Narrative
A supplemental report will be submitted upon receipt of additional information. Not returned to the manufacturer.
 
Event Description
It was reported that a (b)(6) male had emergency cabg surgery on the evening of (b)(6) 2021, came to the icu on a cs300 intra-aortic balloon pump (iabp). During the early hours of (b)(6) 2021 the pump started alarming and they found that the port fill tubing on the safety disk had broken off of the iabp. The customer started manual inflation until another pump was brought to the icu, hooked up the patient to the new pump and continued with therapy. The patient expired later in the day on (b)(6) 2021. The customer sent a picture of the safety disk and iabp asking if it was a common occurrence for the fill port to break off as it did. Upon seeing the picture it was quite obvious the unit had been hit right on the safety disk or manipulated in some way as the safety disk was clocked counter clock wise. I also talked and showed the pictures to service and they agreed and confirmed that is was hit/manipulated. The customer are trying to determine if the iabp going down was a factor in the patient expiring. This report is for the first cs300 iabp. The second iabp is being reported separately and the intra-aortic balloon catheter used in this event has been reported separately under medwatch 2248146-2021-00270.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key11754455
MDR Text Key248244262
Report Number2249723-2021-00917
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-3023-53
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/30/2021 Patient Sequence Number: 1
Treatment
INTRA-AORTIC BALLOON CATHETER
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