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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-53
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Code Available (3191)
Event Date 11/02/2017
Event Type  Injury  
Manufacturer Narrative
The customer biomed reported that he checked the error logs of the cardiosave intra-aortic balloon pump (iabp) and found the alarm documented in the logs. But the biomed could not find any issues causing the error. The biomed connected the iabp to the simulator for testing, disconnected the balloon and the iabp alarmed appropriately. He then checked all the connections and ran the iabp on simulator for several hours with no problems. The iabp was then returned to service.
 
Event Description
Facility perfusionist reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) falsely alarmed ¿iab disconnected". The perfusionist replaced the iabp and assured that all helium connections were secure and that the correct helium extension tubing was used. The second iabp experienced the same alarm and is being reported separately. No death or injury was reported but the customer did report there was a delay in therapy as they had to switch machines which caused some patient instability.
 
Manufacturer Narrative
Corrected: (serial number from (b)(4) to (b)(4)). 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.
 
Event Description
Facility perfusionist reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) falsely alarmed ¿iab disconnected". The perfusionist replaced the iabp and assured that all helium connections were secure and that the correct helium extension tubing was used. The second iabp experienced the same alarm and is being reported separately. No death or injury was reported but the customer did report there was a delay in therapy as they had to switch machines which caused some patient instability.
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date. Additional information has been requested, and we will report accordingly if it becomes available.
 
Event Description
Facility perfusionist reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) falsely alarmed ¿iab disconnected". The perfusionist replaced the iabp and assured that all helium connections were secure and that the correct helium extension tubing was used. The second iabp experienced the same alarm and is being reported separately. No death or injury was reported but the customer did report there was a delay in therapy as they had to switch machines which caused some patient instability.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7054718
MDR Text Key104080202
Report Number2249723-2017-00863
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,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/09/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/22/2016
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: 11/22/2017 Patient Sequence Number: 1
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