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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RW40C
Device Problem Low Readings (2460)
Patient Problems Injury (2348); Blood Loss (2597)
Event Date 12/15/2020
Event Type  Injury  
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. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass the p02 values dropped. Per user facility, the patient undergone replacement of the pulmonary artery valve following previous surgery. After 4 and a half hours of cec the parameters of p02 and pc02 were normal. They stated that the act values were >480 seconds, but the blood sitting stagnant in the pleural space for an unknown period of time (the blood was aspirated from the pleural space after ~4. 5 hours) would not have had an act value of 480 seconds. About 2. 2 liters of blood was aspirated from the pleura, intervention conducted with c02 delivery in the chest between 5-10 liters per minute. There was approximately 300ml of blood loss. The product was changed out. The surgery was completed successfully.
 
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Brand NameSTERILE FX15RWC W/ 4L RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
Manufacturer (Section G)
SAME
Manufacturer Contact
jamie quinlan
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key11123671
MDR Text Key225287184
Report Number1124841-2021-00001
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450790
UDI-Public(01)00699753450790
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*FX15RW40C
Device Catalogue NumberN/A
Device Lot NumberYE06
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/06/2021 Patient Sequence Number: 1
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