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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 Problem Blood Loss (2597)
Event Date 04/30/2018
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). Blood loss. Use of device issue. Results pending completion of evaluation. Conclusion not yet available-evaluation in progress.
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator failed. Per user facility, the partial pressure of oxygen (po2) would not go above 100 at 100%. There was a blood of 300 ml. 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 may 24, 2018. (b)(4). All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
Event Description
Additional clinical information provided: flow rate for majority of the case was 4. 0 lpm which is a 1. 8 indexed flow. The venous saturation were values prior to the oxygenator change out were low 70s. The blood flow rates were ~4. 0 lpm throughout the time frame. The patient was cooled with po2 values in the 250-300 mmhg range. When the patient temperature reached ~33 degrees the po2 values started to decrease (blood flow
=
4. 0-4. 2 lpm) and slowly continued to decrease. Blood flow was never increased. At 14:30 the blood flow was decreased to 2. 7 lpm and the po2 decreased from 143 to 100, at around 14:41 the oxygenator started failing noticeably. The lactate level had increased to 3. 37 at 14:50 and the po2 was 109 at 4. 3 lpm blood flow. At 14:54 blood flow was 4. 0 lpm with a po2 of 76. At 14:15 blood flow was 3. 7 lpm and po2 was 80; at 14:59 arterial blood gas drawn off oxy was: ph-7. 39; pco2-39; po2-76; hct-26%; fio2-100%; sweep-max at blender 11 lpm. After discussion with surgeon, decided we were not ready to come off pump but could temporarily to change out the oxygenator and then go back on to finish repairing some surgical bleeding. Came off bypass at 1530-1532. At 1531 the oxygenator was changed out with an ensuing po2 of 376 at 100%. At 1544 the po2 was 162 at 75%. Next abg on new oxy at 1534 po2-376 @100% fio2. Completed rest of bypass run without any oxygenator problems. *there was delay but the duration is not known.
 
Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations. (b)(4). The complaint sample was not returned for investigation. A gas transfer performance test was conducted whose fiber shares the same fiber lot number with the fiber used for the actual test was reviewed. The test result was confirmed to meet the specifications. Review the involved product / lot number combination confirmed there was no indication of production-related anomaly of nonconforming inspection results. Based on the result of the pump record review, the factors below can be inferred as a cause of this complaint. It is most likely that the blood flow rate during the rewarming was insufficient for the patient's body surface area; by this o2 consumption volume was increased, leading to a decrease in svo2 and decrease in pao2. A definitive root cause could not be determined. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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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
MDR Report Key7542743
MDR Text Key109221708
Report Number1124841-2018-00100
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450837
UDI-Public(01)00699753450837
Combination Product (y/n)N
PMA/PMN Number
K151791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model Number3CX*FX25RWC
Device Catalogue NumberN/A
Device Lot NumberWD12
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/24/2018 Patient Sequence Number: 1
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