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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Device Contamination with Body Fluid (2317)
Patient Problem Abdominal Pain (1685)
Event Date 01/20/2021
Event Type  Injury  
Manufacturer Narrative
At this time, the customer has not requested getinge to evaluate the iabp. There is no information available as to whether parts were replaced/evaluated. A supplemental report will be submitted if further information is provided. (b)(6). Patient height:150cm. Not returned to manufacturer.
 
Event Description
It was reported that the while in use on a patient, the cardiosave intra-aortic balloon pump (iabp) had blood in the helium tubing observed 5 minutes earlier. Additionally, the customers stated that the patient is complaining of new onset abdominal pain. A physician was called to remove the iab and was advised that he could disconnect the balloon from the iabp and power it down. Blood has not reached the pump. Upon followup in the am, the charge nurse reports that the balloon was removed, and another has not been placed. At this time it is unknown if there was another iab placed. A separate report that will send to the report involve iab.
 
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Brand NameCARDIOSAVE
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 Key11330318
MDR Text Key232061369
Report Number2249723-2021-00286
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
Type of Report Initial
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? No
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: 02/15/2021 Patient Sequence Number: 1
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