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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 Failure to Calibrate (2440); Device Displays Incorrect Message (2591)
Patient Problem Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided. There was no alleged malfunction of the iabp. Additional information is being requested, and a supplemental report will be submitted if this information is provided to us.
 
Event Description
Customer reported that during aortic valve replacement, bentall procedure and other unspecified procedures, while transitioning patient from heart lung machine, getinge intra-aortic balloon (iab) was placed. The intra-aortic balloon pump (iabp) indicated that the fiber optic sensor was not calibrated. After many attempts to fix the fiber optic sensor, switching out the iabp and calling getinge representative, the surgeon finally inserted a new iab. During the troubleshooting process, the patient was put back on the heart lung machine and a cabg was performed. After the cabg was completed, another iab was placed and was then taken out because there was leaking around the incision site. A 3rd balloon was then placed in the right femoral artery to fix the leak. Customer states that there was injury to patient which was leak (blood) around the incision site of the femoral artery which could not be controlled. There was no reported malfunction of the iabp, and all indications is that it appropriately alarmed. The date of the event is unknown. Reference mdr 2248146-2018-00177 and 2248146-2018-00268 for the related intra aortic balloon (iab) reports.
 
Manufacturer Narrative
The customer has confirmed that the iabp itself had no problems at the time of this event and is currently working fine without any errors.
 
Event Description
Customer reported that during aortic valve replacement, bentall procedure and other unspecified procedures, while transitioning patient from heart lung machine, getinge intra-aortic balloon (iab) was placed. The intra-aortic balloon pump (iabp) indicated that the fiber optic sensor was not calibrated. After many attempts to fix the fiber optic sensor, switching out the iabp and calling getinge representative, the surgeon finally inserted a new iab. During the troubleshooting process, the patient was put back on the heart lung machine and a cabg was performed. After the cabg was completed, another iab was placed and was then taken out because there was leaking around the incision site. A 3rd balloon was then placed in the right femoral artery to fix the leak. Customer states that there was injury to patient which was leak (blood) around the incision site of the femoral artery which could not be controlled. There was no reported malfunction of the iabp, and all indications is that it appropriately alarmed. The date of the event is unknown. Reference mdr 2248146-2018-00177 and 2248146-2018-00268 for the related intra aortic balloon (iab) reports.
 
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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 Key7441339
MDR Text Key105907081
Report Number2249723-2018-00639
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 09/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received09/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/18/2018 Patient Sequence Number: 1
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