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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ATLAS POSITIONER ATTACHMENT UNIVERSAL STABILIZER ARM

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ATLAS POSITIONER ATTACHMENT UNIVERSAL STABILIZER ARM Back to Search Results
Model Number T401261
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Laceration(s) (1946); Blood Loss (2597)
Event Date 04/05/2018
Event Type  Injury  
Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. (b)(4). Results pending completion of evaluation conclusion not yet available-evaluation in progress.
 
Event Description
The user facility reported to terumo cardiovascular that during the use of the device for cardiopulmonary bypass, the positioner caused 2 centimeter laceration between the layer of fat of cardiac apex and myocardial layer. The laceration was treated by taking a piece of pericardium and sewing it over the area in the form of a patch. There was approximately one hour delay at the end of the procedure to repair the area. It was also reported that the vacuum was set at 30 kpa which is equal to approximately 225 mmhg, still within the limit of 250 mmhg. There was blood loss of less than 100 ml. Product was not changed out. Procedure was completed successfully.
 
Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on apr 27, 2018. The sample was not returned for evaluation nor were any pictures provided; therefore, a thorough investigation could not be performed and a definitive root cause can not be determined. A retention sample from the affected product code/lot number was obtained and visually inspected. No sharp edges or burrs were noted on the cone or anywhere else on the device. The suction test was performed on the retention sample. It was able to provide the suction to the silicone test block, lift it up from the surface and release the suction upon opening the blue vacuum stopcock to the atmosphere. No anomalies were noted when releasing the retention sample from the test silicone block. To replicate the reported event, the suction test was performed again, this time an attempt was made to release the silicone block without turning the blue stop cock to the atmosphere. During this effort it was difficult to release the suction cup from the silicone block. With the reported injury occurring at the end of use, the most likely root cause could be the positioner may have been removed from the heart prior to opening the vacuum stopcock to the atmosphere. Another possible root cause could be the patient's medical condition resulted in increased fragility of the cardiac tissue. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand NameATLAS POSITIONER ATTACHMENT
Type of DeviceUNIVERSAL STABILIZER ARM
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key7468738
MDR Text Key106749397
Report Number1124841-2018-00067
Device Sequence Number0
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
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 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberT401261
Device Catalogue NumberN/A
Device Lot Number00065
Other Device ID Number(01)00699753450622
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
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: 04/27/2018 Patient Sequence Number: 1
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