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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)
Event Date 12/20/2017
Event Type  Death  
Manufacturer Narrative
Corrected fields: (catalog# & (b)(4) (evaluation method, results and conclusion codes). The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed. There were no non-conformances in the production dhr related to the reported event. A getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit and was unable to duplicate the reported issues of ¿system failure¿. However, the fse was able to verify the occurrence in the diagnostic error logs along with electrical test failure #53. All cable connections were checked and were ok. The fse verified the iabp unit calibrated and passed all fiber optic, leak, functional and safety tests. The unit was power cycled multiple times and powered up normally. The iabp unit was returned to customer and cleared for clinical use.
 
Event Description
It was reported that a cs300 intra-aortic balloon pump (iabp) was used for a cardiac catheterization on a patient with non-st-elevation myocardial infarction (nstemi) and left main disease. The patient went into cardiogenic shock; two vasopressors were started but the patient's blood pressure very low and the staff was unable to establish a trigger. The iabp was turned on and displayed "system failure" when the catheter was connected. The unit was restarted and powered up without an issue. After treating the patient and the blood pressure increased they were able to deliver therapy. The iabp was subsequently switched with another iabp to continue with therapy, due to concerns of the alarm on power-up. The patient expired two (2) days later, and the customer does not attribute the death to the iabp. This report is for the 1st iabp used in therapy which is also related to the balloon report which will be submitted under mfg report number 2248146-2018-00027.
 
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per sop since the serial number for the unit was not provided. At this time, the customer has not requested getinge to evaluate the iabp. If additional information is made available, a supplemental report will be submitted.
 
Event Description
It was reported that an unknown intra-aortic balloon pump (iabp) was used for a cardiac catheterization on a patient with non-st-elevation myocardial infarction (nstemi) and who also had left main disease. Subsequently, the patient went into cardiogenic shock and two vasopressors were started and the patient's blood pressure was still not reading. The iabp was turned on and displayed "system failure" when the catheter was connected. The iabp was switched with another to continue with therapy. The patient expired five (5) days later, and the customer does not attribute the death to the iabp. This report is for the 1st iabp used in therapy which is also related to the balloon report which will be submitted under (b)(4).
 
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Brand NameCS300
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 Key7183924
MDR Text Key104302545
Report Number2249723-2018-00048
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
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: 01/11/2018 Patient Sequence Number: 1
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