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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25RWC
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Blood Loss (2597)
Event Date 12/04/2017
Event Type  malfunction  
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 december 20, 2017 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 fda in accord with applicable regulations. The returned sample was visually inspected upon receipt and did not find any anomalies, such as break. After having been rinsed and dried, actual sample was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol. No anomalies were revealed and the obtained values met the factory specifications. The investigation result was confirmed to be normal product with no issue in the gas transfer performance. 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.
 
Event Description
When the sample was received for investigation, it was noted that the reported oxygentaor was not completely changed out. Another oxygenator unit was added and used in tandem.
 
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 conclusion code. (b)(4). Results code: results pending completion of evaluation. Conclusion code: conclusion not yet available-evaluation in progress.
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass procedure, the partial pressure of oxygen (po2) was very low. There was minimal blood loss. The product was changed out. Procedure was completed successfully.
 
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Brand NameSTERILE FX25RWC W/ RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key7137066
MDR Text Key249629638
Report Number1124841-2017-00260
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model Number3CX*FX25RWC
Device Catalogue NumberN/A
Device Lot NumberVL04
Other Device ID Number(01)00699753450837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2017
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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