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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 Use of Device Problem (1670)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2022
Event Type  malfunction  
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed bubbles coming up through the reservoir from the centrifugal inlet. As per user facility, while recirculating, they noticed bubbles coming up through the reservoir from the centrifugal inlet. Bubbles were also seen in the rear, seen both from front and back. And when we stopped recirculating, the venous line de-primed by a foot or more. This occurred with shunts closed. The pump was changed out. They double-checked all the luers and connections and were tightly closed. When the system was running, its negative pressure on the venous line likely caused cavitation of microbubbles into the fluid-filled part of the reservoir. This issue persisted even with a large amount of circulating prime volume so the point of entry for air must have been closer to the top of the venous inlet tube. When the system was turned off, being open to air somewhere along the tube allowed the venous line to completely de-prime. It is unknown if there was a delay, if the surgery was completed successfully, if it caused or contributed to an injury to the patient or if there was a blood loss. Terumo continues an attempt to gain more information regarding this event from the user facility. Product was changed out.
 
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).
 
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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 (Section G)
SAME
Manufacturer Contact
jamie quinlan
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key14242419
MDR Text Key291314326
Report Number1124841-2022-00097
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450837
UDI-Public(01)00699753450837
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 Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*FX25RWC
Device Catalogue NumberN/A
Device Lot Number2A17
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2022
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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