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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RWC W/ 3L RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RWC W/ 3L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RW30C
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 12/06/2016
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). Results: results pending completion of evaluation. Conclusions: conclusion not yet available - evaluation in progress.
 
Event Description
The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during setup, the perfusionist noticed a crack in the arterial side stop cock of the sampling port. No patient involvement as this occurred during setup. Product was changed out. Surgery 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 december 19, 2016. Upon further investigation of the reported event, the following information is new and/or changed: (b)(4). The sample was returned for evaluation. A review of the device history record revealed no manufacturing anomalies. The returned sample was visually inspected. A crack along the female l-shaped connector was found, while still connected to the luer port. A retention sample from the same product code and lot number combination was visually inspected and confirmed to not have any damages or cracks on the l-shaped connector. Replication testing was performed on a retention sampling manifold line. The l-connector was over-tightened onto a port of the reservoir, which lead to the l-connector cracking along the part, in the same way as the returned sample. It is likely that during setup of the circuit, the l connector been over-tightened, causing it to crack. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand NameSTERILE FX15RWC W/ 3L 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 Key6187036
MDR Text Key62793315
Report Number1124841-2016-00432
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151389
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 01/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model Number3CX*FX15RW30C
Device Catalogue NumberN/A
Device Lot NumberUA25
Other Device ID Number(01)00699753450783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2016
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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