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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RW OX W/ 3L RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RW OX W/ 3L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RW30
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2017
Event Type  malfunction  
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 june 30, 2017. Upon further investigation of the reported event, the following information is new and/or changed: (date received by manufacturer). (indication that this is a follow-up report). (follow-up due to additional information). The sample was not returned for evaluation; therefore, a complete investigation was not able to be performed. The vinyl caps are meant to be easily removed by the customer when ready for setup, in order for the user to connect tubing to the desired ports. As the caps are not bonded to the ports in anyway, and this specific port is barbed only, with no threads, the cap is easily able to be removed. Through shipping and handling the cap may have slid off of the port. As the customer reported that the cap remained in the packaging, it had been present on the port at the time of packaging during manufacture. This is not a functional issue and is considered a customer preference issue. 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. For this reason, terumo references evaluation conclusion code. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during out of box, the blue cap on the venous reservoirs is almost always off and is in the packaging. No patient involvement as this occurred during out of box.
 
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Brand NameSTERILE FX15RW OX 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 Key6682024
MDR Text Key196699995
Report Number1124841-2017-00126
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
Type of Report Initial,Followup
Report Date 07/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*FX15RW30
Device Catalogue NumberN/A
Device Lot NumberN/A
Other Device ID Number(01)00699753450745
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 Received07/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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