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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
Model Number N/A
Device Problems Calibration Problem (2890); Device Operates Differently Than Expected (2913)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 05/04/2018
Event Type  malfunction  
Manufacturer Narrative
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. A getinge field service engineer (fse) evaluated the iabp and performed running test in getinge office, and the reported incident was not duplicated. The iabp worked normally and all functional and safety tests were passed per factory specifications, thus no parts were replaced. The iabp was returned to the customer and has been released for clinical use.
 
Event Description
It was reported that after the intra-aortic balloon (iab) was inserted into a cardiopulmonary arrest patient, the optical sensor was unable to take the arterial pressure since the catheter was located in the patient. Although attempts were made to connect it with the sensor connector, it was unable to take a calibration. The cardiosave iabp was replaced with a cs100 to continue therapy; however, the arterial pressure was unreadable. The surgeon had an impression of the catheter failure, and used the monitor kit from another line to measure arterial pressure instead of the optical sensor. Three days later they removed the iab and discontinued iabp therapy. No patient harm or adverse event was reported.
 
Manufacturer Narrative
Correction of date in initial mdr: please note that the date in the initial mdr was erroneously reported as (b)(4) 2018 but should read (b)(4) 2018.
 
Event Description
It was reported that after the intra-aortic balloon (iab) was inserted into a cardiopulmonary arrest patient, the optical sensor was unable to take the arterial pressure since the catheter was located in the patient. Although attempts were made to connect it with the sensor connector, it was unable to take a calibration. The cardiosave iabp was replaced with a cs100 to continue therapy; however, the arterial pressure was unreadable. The surgeon had an impression of the catheter failure, and used the monitor kit from another line to measure arterial pressure instead of the optical sensor. Three days later they removed the iab and discontinued iabp therapy. No patient harm or adverse event was reported.
 
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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 Key7580888
MDR Text Key110630466
Report Number2249723-2018-00967
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-XX
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received09/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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