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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 Problems Improper Flow or Infusion (2954); Pressure Problem (3012)
Patient Problem Blood Loss (2597)
Event Date 10/31/2019
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. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator was working but flow reduced to about 1. 5 l per minute. As per the user facility, they received an email about the fx15 being swapped out due to a pressure excursion. As per the perfusionist, the patient had an adequate anti coagulation and good act xclamp still on about 20 minutes into the case. The patient was warm, and believed that the changes rose over a short period of 300 with the post pressure rising to around 500 ml hg. They were able to swap out the fiber bundle with a 30 ml blood loss as they sequestered almost all of it into the reservoir. The oxygenator was replaced and it performed well without pressure excursion, and the case was continued without further incident or patient harm. No known impact or consequence to patient. There was a delay for approximately 10 minutes while changing out. The procedure 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
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key9365036
MDR Text Key168838560
Report Number1124841-2019-00316
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 company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/03/2019
Device Model Number3CX*FX15RW40C
Device Catalogue NumberN/A
Device Lot NumberXG03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2022
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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