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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25REC
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/12/2021
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, they noticed a reduced oxygenation performance. As per subsidiary, "the perfusion was performed with hypothermia at 32°c. Act after 33,250 iu heparin bolus, before ecc onset at 475 sec. Act 15 min after ecc start at 396 sec. ; then heparin administration of 15,000 iu. Subsequent act control > 1000 sec. Approx. 40 minutes after the start of the ecc (around 13:00), first occurrence of reduced oxygenation performance measured due to decreasing po2 with constant pco2, without any abnormalities in the pressure difference attributable to the oxy. Increase in fio2 with constant gas flow. Around 13:20 po2 continued to fall with a simultaneously increased fio2 and gas flow. Approx. At 13:26 clearly falling saturation values in the nirs (regional oximetry of the head). Nonin: fell below 10% of the baseline cdi: po2 increased from 7x to 9x with each increase in the gas values increase of the gas flow to 10l/min and fio2 100% no abnormalities with pressure difference of the oxy or blood flow rate. Decision to exchange oxy by changing the complete hlm. New machine brought into the surgery room both machines aligned to swap gas settings of the new machine to 100% and 8 liters electricity and gas of the new machine connected. Standstill announced, running machine stopped at 13:28:00 vein and artery clamped venous tubing repositioned arterial tubing repositioned and vented exchange of data transfer to the jocap computer (maquet) blood volume of the old machine moved into the new machine via the hemofilter. The interruption of the circulation lasts approx. 2 minutes at a body temperature of 32°c. Immediate normalization of the saturation values in the patient, once the ecc was resumed with a new hlm. No known impact or consequence to patient. Product was changed out. Procedure was completed successfully.
 
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Brand NameSTERILE FX25REC 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 Key12124163
MDR Text Key260451124
Report Number1124841-2021-00164
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,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberYF04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2020
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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