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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 Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2020
Event Type  malfunction  
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). Results: results pending completion of investigation; conclusions: conclusion not yet available.
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a decreased performance of oxygenator during run. Per clinical specialist the patient was in for placement of left ventricle assist device (heartmate 3). The lactate levels were high (>4), the ph was acidotic with base deficits of >-7. 5, low hco3 levels. The first act level was 999, which is not considered a measurable level so it's unknown as to what the true anticoagulation level was at that point in time, also it was mentioned that patient had high bilirubin level. The po2 values were good, the pco2 values were slightly elevated, arterial saturations, the venous saturation values, hemoglobin and hematocrit were all good. The do2 values were adequate. The patient has no urine output per the record attached, there was 3900 ml of volume removed via hemofiltration. No known impact or consequences to patient; the product was not changed out; the surgery was 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 Key10632080
MDR Text Key219177872
Report Number1124841-2020-00233
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
Report Date 11/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2020
Is this an Adverse Event Report? No
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 Manufacturer09/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2019
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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