• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Model Number 3CX*FX25RWC
Device Problems Insufficient Flow or Under Infusion (2182); Defective Device (2588)
Patient Problems Injury (2348); Blood Loss (2597); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
Terumo has received the device for evaluation; however, 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 failed to oxygenate. As per the distributor, they have confirmed this failure occurred prior to bypass and was detected by the perfusionists who uses bottles oxygen to test during setup. He also spoke to the clinical specialist and the two perfusionists who were on the case. The bypass was initiated and the oxygenator failed within 5 minutes of initiation. Perfusion came off pump, anesthesia ventilated the patient and they changed out the oxygenator without incident. The account routinely tests every oxygenator prior to bypass. This oxygenator was tested after the failure in the pump room using the same method and it was confirmed that it would not oxygenate. Also, as per the sales associate, there was a delay for 10 minutes and 800cc of blood loss. As per the clinical specialist, the account routinely tests every oxygenator prior to bypass for gas exchange using the cdi 550. The oxygenator tested okay prior to cpb but when they went on bypass, the blood did not turn bright red, it got darker. The initial sweep gas was 3. 0 lpm , fio2 was 65% at ~4 lpm blood flow. The perfusionist turned the sweep gas to 8 lpm and fio2 to 100% but blood was still dark, they checked all connections, hooked up an oxygen tank to the oxygenator and that did not resolve the problem so they decided to change out the entire hlm. Additionally, the patient had coronary artery disease, was a smoker and with previous exposure to heparin. The procedure performed was a cabg (coronary artery bypass grafting). On bypass approximately 5 minutes then changed out entire heart-lung machine, not just the oxygenator. Patient¿s heart was still beating, anesthesia ventilated patient so there was adequate metabolic support of the patient during the change out of the heart-lung machine. The initial dose of heparin administration was approximately 5 minutes in between the initiation of the cpb. The blood gas values pre and during cpb prior to the oxygenator changed out was; 0901 7. 47, 32, 171, 22, 0; 0927 7. 43, 38, 87, 25, 1; 1000 7. 42, 34, 426, 22, -2 and the act values prior to and during cpb was at 642. The temperature of the patient at the time of the oxygenator changed out was 36 degrees. Venous saturation was low, and venous blood was very dark. The hgb and hct values were, 40% hematocrit, hemoglobin 13. 5 at initiation of cpb. Heparin level was also monitored at 3. 0. The product was changed out. Procedure was completed successfully.
Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on november 16, 2020. Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 4739, 4614, 4604, 4582, 2182, 10, 3331, 213, 67). Components code: 4739 - gas exchanger. Health effect - impact code #1: 4614 - serious injury/ illness/ impairment. Health effect - impact code #2: 4604 - delay to treatment/ therapy. Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions. Medical device problem code: 2182 - insufficient flow or under infusion. Type of investigation #1: 10 - testing of actual/suspected device. Type of investigation #2: 3331 - analysis of production records. Investigation findings: 213 - no device problem found. Investigation conclusions: 67 - no problem detected. The returned sample was visually inspected upon receipt with no break or other obvious anomaly that would lead to decrease in oxygenation performance. After having been rinsed and dried, it was then tested for the o2 transfer volume and co2 removal volume in accordance with the factory's inspection protocol. No anomalies were revealed in the oxygenation performance of the actual sample, with the obtained values meeting the factory's control criteria. During the performance test, the arterial blood color was confirmed to be brighter that the venous blood color. The investigation result verified that the actual sample after having been rinsed, was the normal product with no issue in the oxygenation performance. All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
125 blue ball road
elkton MD 21921
Manufacturer (Section G)
Manufacturer Contact
jamie quinlan
125 blue ball road
elkton, MD 21921
MDR Report Key10848610
Report Number1124841-2020-00262
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450837
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2023
Device Model Number3CX*FX25RWC
Device Catalogue NumberN/A
Device Lot NumberYH13
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Outcome(s) Other;