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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 3000 ML BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 3000 ML BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*RX15RW30
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2020
Event Type  malfunction  
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). Results: results pending completion of investigation. Conclusions: conclusion not yet available.
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary, at the time of entry in partial extra-corporary circulation, the patient saturation began to go down, reaching 70%. It is unknown if there is blood loss. As per subsidiary, it was noticed that the post oxygener blood side¿s coloring was equal to the insatured venous return. Immediately, an arterial gasometry was made where the oxygen partial pressure (po2) was 35. 2 mmhg, and the saturation of oxygen was 62. 1%. It was processed to connect an oxygen tank to the oxygenator, thinking that it could be the blender of the heart-lung machine, and the result was the same so the anesthesiologist was requested to increase the fraction of inspired oxygen (fio2) of the ventilator to remove the pump patient, and can replace the oxygenator to an rx25, and this works. No known impact or consequence to patient. Product was changed out. Procedure completed successfully.
 
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Brand NameHOLLOW FIBER OXY WITH 3000 ML
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 Key10588401
MDR Text Key209002135
Report Number1124841-2020-00227
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Model Number3CX*RX15RW30
Device Catalogue NumberN/A
Device Lot NumberTP14
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2015
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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