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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25REC W/RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25REC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3ZZ*FX25RECA
Device Problem Device Issue (2379)
Patient Problems Injury (2348); Blood Loss (2597)
Event Date 09/20/2017
Event Type  Injury  
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 october 20, 2017. The actual sample was not returned so a thorough investigation of the reported event could not be performed. However, retention sample from same lot # venous reservoir filter was obtained. Visually inspected the retention sample, no anomalies were found. The sample was then connected to a circuit, and the reservoir clotting test was performed on the retention sample, which included circulating bovine blood through the unit for one hour at a high flow rate (7l/min). At the completion of the hour, the blood was drained and the unit was rinsed with di water. There were no clots located within the venous filter. The reported event was unable to be replicated; therefore, a definitive root cause was not able to be determined. It is likely that patient conditions contributed to the formations of clots within the reservoir filter. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, an hour and 43 minutes into the procedure, the bubble alarm went off and a clot had formed inside the venous return sock on the cardiotomy reservoir. There was blood loss of 200 cc. There was a delay for 3 minutes. The product was changed out. Procedure was completed successfully.
 
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Brand NameNS FX25REC W/RES
Type of DeviceBLOOD GAS OXYGENATOR
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 Key6966130
MDR Text Key249629843
Report Number1124841-2017-00216
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151791
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 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model Number3ZZ*FX25RECA
Device Catalogue NumberN/A
Device Lot NumberVF29
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2017
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: 10/20/2017 Patient Sequence Number: 1
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