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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS STERILE FX25RW OXY W/ RESERVOIR; BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS STERILE FX25RW OXY W/ RESERVOIR; BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25RW
Device Problem Dent in Material (2526)
Patient Problem No Patient Involvement (2645)
Event Date 12/10/2015
Event Type  malfunction  
Manufacturer Narrative
Terumo has received the actual 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 more information becomes available.(b)(4).
 
Event Description
The user facility reported to terumo cardiovascular systems that prior to cardiopulmonary bypass, during setup, the venous inlet of the oxygenator was dented.There was also a tear in the blue inlet port caps.No patient involvement as this occurred during setup.Product was changed out.Surgery as completed successfully without delay.
 
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 to the fda on december 23, 2015.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 device evaluation).(device evaluated by manufacturer).(b)(4).The actual sample was visually inspected upon receipt, during which it was confirmed that there was damage to the blood inlet port of the oxygenator and to the cardiotomy port cap on the reservoir lid.No other damages were noted on the device.A review of the device history record revealed no anomalies.All units are 100% visually inspected during final assembly and packaging.The damage to the port and cap was most likely due to an extreme external force being applied to the product at some point after final release, during shipping and handling; however, a definitive root cause could not 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 Name
STERILE FX25RW OXY W/ RESERVOIR
Type of Device
BLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS
125 blue ball road
elkton MD 21921
Manufacturer Contact
robyn o'donnell
125 blue ball road
elkton, MD 21921
8002623304
MDR Report Key5323940
MDR Text Key34277940
Report Number1124841-2015-00338
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2018
Device Model Number3CX*FX25RW
Device Lot NumberTL28
Other Device ID Number(01)00699753450479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/10/2015
Initial Date FDA Received12/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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