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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25REC
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 02/03/2016
Event Type  malfunction  
Manufacturer Narrative
Terumo has received the device for evaluation; however, 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. For this reason, terumo references evaluation conclusion. (b)(4). Conclusion not yet available-evaluation in progress.
 
Event Description
The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, while unboxing the product, the c-ring that secures the reservoir to the oxygenator had popped off. It could not be put back on as it was too tight. *no patient involvement as this was found out of box.
 
Manufacturer Narrative
The returned sample was visually inspected and it was found that the c-ring on the sample, that holds the neck to the reservoir, was not in place. No damages were noted anywhere on the device. The c-ring was able to be put back into place; however, it seemed to be a loose fit and easily removed again. A retention sample from product code 3cx*fx25rec lot tp14 was obtained and confirmed to have the c-ring in its proper place. The c-ring was then able to be manually detached from the device and put back into place. The connection of the c-ring to the neck seemed to be more secure than that of the returned complaint sample. Each connecting ring is put into place using a mechanism on the reservoir leak tester in production. The leak test will not start until the handle is positioned properly over the connecting ring indicating that it has been properly put in place attaching the reservoir to the lid. All products are 100% visually inspected to ensure that the connecting ring is fully seated at each side and there isn't a loose connection. It is possible that there had been some damage to the c-rings at some point during the production process or shipping and handling that caused them to have a loose connection on the product. 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 CORPORATION
125 blue ball road
elkton MD 21921
Manufacturer Contact
shari bailey
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key5460583
MDR Text Key39035652
Report Number1124841-2016-00071
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2018
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberTM28
Other Device ID Number(01)00699753450820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2015
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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