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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25REC W/RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25REC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25REC
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 10/13/2016
Event Type  malfunction  
Manufacturer Narrative
Terumo has not received the actual 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 more information becomes available. (b)(4).
 
Event Description
The company representative reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during setup, the manifold on the oxygenator was broken when opened. No patient involvement as this occurred during setup. Product was change out. Surgery was completed successfully.
 
Manufacturer Narrative
The sample was not returned for evaluation. A review of the device history record revealed no manufacturing anomalies. A retention sample from the same product code/lot number combination was visually inspected and confirmed to not have any damages or anomalies, specifically with the manifold. A definitive root cause could not be determined; therefore, this complaint is not confirmed. All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
 
Manufacturer Narrative
This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted. (b)(4). The sample was returned on december 12, 2016, after the final medwatch was sent on november 18, 2016. Visual inspection was performed on the returned sample. It was confirmed that two of the three stopcocks on the sampling manifold were damaged. One of the yellow non-vented caps was broken and shattered, and the port of the other stopcock was broken off along with the yellow non-vented cap being shattered off of the port. A retention sample from the same product code/lot number combination was visually inspected and confirmed to not have any damages or anomalies, specifically with the manifold. It is likely that the manifold had been damaged during shipping and handling by an external force; however, when or how this force was applied to the sampling manifold could not be determined. All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
 
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Brand NameSTERILE FX25REC W/RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key6077357
MDR Text Key59221324
Report Number1124841-2016-00376
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,Followup
Report Date 12/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberUG13
Other Device ID Number(01)00699753450820
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 Received12/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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