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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RE OX W/ 3L RES; BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RE OX W/ 3L RES; BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RE30C
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 03/23/2017
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 (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the oxygenator has a missing temperature port.No patient involvement.Product was changed out.Procedure completed successfully.
 
Manufacturer Narrative
The returned sample was visually inspected and it was found to not have the thermistor in the oxygenator port as it should.There was also no evidence of chemical presence in the empty port.Review of the product's dhr found that the specific serial number of the returned sample had passed final visual inspection, confirming that the thermistor had been present in the port at the time of packaging.It is likely that the thermistor had been inserted into the port of the oxygenator, but never dipped into the chemical to bond it into the port, allowing it to come loose and not be present at the time of use.A retention sample from the same product code/lot number combination was visually inspected and confirmed to have a thermistor properly bonded within the oxygenator port.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 FX15RE OX W/ 3L RES
Type of Device
BLOOD 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 Key6463632
MDR Text Key72339960
Report Number1124841-2017-00056
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 Other
Type of Report Initial,Followup
Report Date 05/04/2017
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 Date09/30/2019
Device Model Number3CX*FX15RE30C
Device Catalogue NumberN/A
Device Lot NumberUM10
Other Device ID Number(01)00699753450448
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/23/2017
Initial Date FDA Received04/06/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2016
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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