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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tachycardia (2095); Low Cardiac Output (2501)
Event Date 05/09/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6). The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Cardiosave iabp complaint reported under mfg report number 2249723-2020-00837. Complaint record id # (b)(4).
 
Event Description
It was reported that the touchscreen of the cardiosave intra-aortic balloon pump (iabp) stopped functioning. The iabp went into standby mode. The iabp was restarted and the touchscreen worked for 5 minutes then stopped working again. It was later reported that the patient came in to pci team with stemi and cardiogenic shock. Occluded marginal branch and papillary muscle rupture were noted. Iabp was established and the patient was admitted for emergency surgery. In this situation, the patient was completely dependent on the iabp. Patient sternotomeras and we went to ecc. Kept iabp on auto 1:1 until pliers were set. Turns iabp to standby and changes settings to internal and restarts. Retains this during the clamping time. When the tongs are released, iabp is started at semi-automatic 1: 3 and we start weaning by ecc. Goes up to 1: 1. The patient begins to become tachycardic and requires a lot of inotropes as well as iabp to maintain map> 60. The chief surgeon indicated he wanted to evaluate the ventricular function and ask that the iabp stop briefly. The iabp was put on standby. After evaluation, the iabp could not be restarted but could now not get out of standby mode. Meanwhile, the patient's map drops to <30. After pressing anywhere on the screen for a few minutes, customer tried to turn off iabp completely and restart it. After doing this iabp came out of standby mode but cannot start, i. E. , they could not use the touch screen. They then decided to change the iabp to another iabp. Thereafter, the patient could be successfully weaned from the ecc using the iabp. There was no reported malfunction on the balloon.
 
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Brand NameUNKNOWN IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key10113049
MDR Text Key195314982
Report Number2248146-2020-00272
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/02/2020 Patient Sequence Number: 1
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