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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 Pressure Problem (3012)
Patient Problem Blood Loss (2597)
Event Date 01/30/2019
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).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a high pressure excursion was noted. They were on cpb ~5 minutes when the event occurred. They rapidly initiated bypass. 30,000 units of heparin was given to patient and another 30,000 units of heparin was put in pump prime prior to initiation of bypass. Low pump flow, high rpm, and high transmembrane pressure drop were noted. An additional oxygenator was primed and readied for exchange. The low pump flow and high rpm conditions resolved and the high transmembrane pressure drop resolved over the course of the procedure. There was a delay for 2 minutes. There was a blood loss of 50-75 cc. The product was changed out. The procedure 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
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key8342698
MDR Text Key136323387
Report Number1124841-2019-00046
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model Number3CX*FX15RW40C
Device Catalogue NumberN/A
Device Lot NumberWM29
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2018
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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