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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 Decrease in Pressure (1490)
Patient Problem Blood Loss (2597)
Event Date 08/19/2020
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, they noticed dropping of oxygenation. As per user facility the patient came in at (b)(6) hospital (b)(6) on (b)(6) 2020 with symptoms constant coughing, nausea , pain upper left stomach area. His condition became worse , transfer to university hospital leuven. According perfusionist he developed multiple organ failure like kidney issues, liver failure and cardiogenic shock. The procedure was placement of left ventricular assist device (lvad) heart ware on a patient during bypass, however prior to the lvad first impella was placed for left ventricle support but system needed to change out to another impella, but failed again. The left ventricle support was not enough. The case was started around 2:57pm, cdi 500 was used and oxygenation from the start was perfect. First blood gas sample at 15. 15pm with an fio2 of 60% and 2l flow po2
=
251 pco2
=
36. The second blood gas sample at 15. 24pm with an fio2 of 100% plus 10lgasflow po2 dropped to 84 and pco2 went up to 43, even went to po2
=
73. The cdi500 gave the same information and they decided to changed out the oxygenator. At around 15. 40 pm they changed out the oxygenator at first 100%fio2 at 2. 5 l/flow, po2
=
503 pc02 31. At first the values were fine. After 20 minutes the same event as above occurred. Cdi 500 gave decreasing po2 levels and increasing pco2 levels. No data was stored and no extra blood gas samples were taken. On pump time was 71 minutes and they decided to wean the patient immediately using cdi. Blood loss estimated 1 liter (cellsaver). Product was changed out. Procedure 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
jamie quinlan
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key10504582
MDR Text Key206170750
Report Number1124841-2020-00211
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,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*FX15RW40C
Device Catalogue NumberN/A
Device Lot NumberXK12
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/30/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/08/2020 Patient Sequence Number: 1
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