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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 02/07/2018
Event Type  malfunction  
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.
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the pig tail on the oxygenator fell off no patient involvement as this occurred during setup, there was a delay in order to change out the oxygenator. Product was changed out, procedure 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 february 27, 2018. (b)(4). The returned sample was visually inspected upon receipt. It was confirmed that the pigtail line was detached from the oxygenator blood outlet port. A retention sample from the affected product code/lot number combination was obtained and visually inspected and it confirmed that the pigtail line was properly bonded to the port and attached without damage. All capiox units are 100% visually inspected at several points in the production process. It is likely that the line was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to 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 CORPORATION
125 blue ball road
elkton MD 21921
MDR Report Key7298979
MDR Text Key101348460
Report Number1124841-2018-00031
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K151791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberVN13A
Other Device ID Number(01)00699753450820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

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