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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 4L RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 4L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RE40C
Device Problem Pressure Problem (3012)
Patient Problem Blood Loss (2597)
Event Date 09/16/2019
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 (cpb), short after starting the heart lung machine (hlm), pressure increase of the oxygenator. Per user facility, a few minutes after cpb for aorto-coronary bypass surgery, the pre oxygenator pressure started rising gradually whereas the post oxygenator pressure was constant. After 7 min of cpb, the pre oxygenator pressure rose to 500 mm hg abruptly with the delta p of 250 mm hg, and the pump was completely stopped due to high pressure. The act during that particular moment was 508 sec. After they informed the surgeons, two of the perfusionists changed the whole machine within 7 minutes. During this maneuver, the aorta was not clamped, hence he was ventilated and he was hemodynamically stable. *no consequences or impact to patient *product was changed out *there was 300 ml blood loss *procedure was completed successfully.
 
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Brand NameSTERILE FX15REC 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
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key9160288
MDR Text Key162528145
Report Number1124841-2019-00274
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 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model Number3CX*FX15RE40C
Device Catalogue NumberN/A
Device Lot NumberXD11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2019
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: 10/06/2019 Patient Sequence Number: 1
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