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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 Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
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, oxygenator flow was reduced and high pressures were noted. This was discovered after 93 minutes on cpb. There was no pressure excursion noticed in the membrane and oxygenation function appeared normal. However flows were reduced through the device and high pressures were noted through digital palpation on the outflow of the device. There was a delay due to changing out the oxygenator. This necessitated removing the cross clamp from the aorta and coming off bypass. As the heart had not regained normal sinus rhythm the surgeon performed open cardiac massage while the perfusion team changed out the device. Approx. Time off cpb was 5-7 minutes to complete change out. Patient recovered normally in cvicu post-op. 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 (Section G)
SAME
Manufacturer Contact
jamie quinlan
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key11375434
MDR Text Key241305509
Report Number1124841-2021-00026
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,foreign,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number3CX*FX25RWC
Device Catalogue NumberN/A
Device Lot NumberYK10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2020
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: 02/24/2021 Patient Sequence Number: 1
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