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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 Problem Use of Device Problem (1670)
Patient Problem Blood Loss (2597)
Event Date 05/02/2018
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).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, low flow of 1. 3 lpm was noted with a high oxygenator inlet pressure of 325 mmhg. The patient was scheduled for an elective cabg procedure. Patient was intubated and anesthetized with all appropriate lines placed. The patient's blood pressure dropped markedly and the decision was made to emergently initiate cardiopulmonary bypass. The patient was systemically anti-coagulated while the pericardium was divided and purse string sutures were placed. Act was measured at 405 seconds prior to initiation of bypass. A 20000 units of additional heparin were introduced to the pump prime. Upon initiation of bypass the low flow/high inlet pressure issue occurred. Oxygenator outlet pressure was 70 mmhg at this time. The aorta was assessed for possible dissection at the cannulation site. Venous return was adequate and there was no visible clot of obstruction in the venous reservoir, centrifugal pump head, or oxygenator. The decision was made to change the oxygenator and venous reservoir. The patient was weaned from bypass with better heart function and blood pressure than prior to bypass but still decreased. Full bypass was reinitiated with normal line pressures in the entire circuit and adequate flows. *there was blood loss of about 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 21, 2018. (b)(4). The sample was not returned for evaluation; therefore, a thorough investigation could not be performed and definitive root cause can not be determined for this event. A performance test was conducted on a representative sample of a subassembly product and it was confirmed that the test results met the specifications as related to the reported event. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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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
MDR Report Key7532050
MDR Text Key108852634
Report Number1124841-2018-00098
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450790
UDI-Public(01)00699753450790
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
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model Number3CX*FX15RW40C
Device Catalogue NumberN/A
Device Lot NumberWC05
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/22/2018 Patient Sequence Number: 1
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