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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15REC W/ 4L RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15REC W/ 4L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RE40C
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 11/21/2016
Event Type  malfunction  
Manufacturer Narrative
Terumo has not received the actual device; 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).
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up, the port where the sensor plugs in fell off when attempting to plug in the sensor on set up. There was no patient involvement as this occurred during setup. Product was changed out. Procedure was completed successfully.
 
Manufacturer Narrative
A second follow-up will be submitted upon completion of the investigation and/or submission of new information. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
Manufacturer Narrative
This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted. (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. It was found that the thermistor on the oxygenator was broken. The external portion of the thermistor appeared to have sheared off of the port or insert, which remained within the oxygenator port. A retention sample from the sample product / lot family was visually inspected and confirmed to have no damages. The thermistor was properly attached to the oxygenator port. All capiox units are 100% visually inspected at several points in the production process. It is likely that the thermistor 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 FX15REC W/ 4L 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 Key6154166
MDR Text Key61715921
Report Number1124841-2016-00417
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model Number3CX*FX15RE40C
Device Catalogue NumberN/A
Device Lot NumberUF23
Other Device ID Number(01)00699753450813
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2016
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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