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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25RWC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3ZZ*FX25RWCA
Device Problem Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2016
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, (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the venous prime fluid temperature is reading higher than the arterial outlet temperature by about 1 degree c. No known impact or consequence to patient. Product was not 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 october 28, 2016. 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
The sample was returned for evaluation. A review of the device history record revealed no manufacturing anomalies. The returned sample consisted of only the oxygenator, with the arterial thermistor. Visual inspection of the returned sample found no anomalies, specifically around the thermistor. The unit was setup in a circuit and water was circulated through the unit. The temperature of the water from the water supply was measured as well as the temperature of the fluid at the oxygenator's thermistor. The temperatures of the fluid at both locations matched exactly. The reported event was not able to be replicated and the complaint was not confirmed. If temperatures are taken at two separate locations and then compared, the variability in the fluid may cause the temperatures to truly be different at these different locations. The temperature at the venous thermistor is likely to vary from the temperature at the arterial thermistor, especially due to the fluid going through the heat exchanger between these two locations. If temperatures are read at a time that the fluid is being warmed or cooled, and a steady state temperature is not achieved prior to measuring this temperature, this will also cause a difference in readings. All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
 
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Brand NameNS FX25RWC W/RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball rd
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball rd
elkton, MD 21921
8002837866
MDR Report Key6063460
MDR Text Key58662711
Report Number1124841-2016-00367
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model Number3ZZ*FX25RWCA
Device Catalogue NumberN/A
Device Lot NumberUK01
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2016
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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