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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25RWC
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 06/29/2017
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 july 18, 2017. (b)(4). Upon evaluation of the returned sample, it was confirmed that the blood outlet cap on the reservoir had fallen off while in the packaging. These 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 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 code. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during out of box, the oxygenator venous reservoir caps have fallen off. There was no patient involvement.
 
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Brand NameSTERILE FX25RWC 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 Key6721334
MDR Text Key205260117
Report Number1124841-2017-00147
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 08/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model Number3CX*FX25RWC
Device Catalogue NumberN/A
Device Lot NumberVF22
Other Device ID Number(01)00699753450837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2017
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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