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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25REC W/RES; BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25REC
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Information (3190)
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).
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up the temperature probe was loosen.It is unknown whether the product was changed out, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.
 
Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on june 23, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer, method code #2: 3331 - analysis of production records, method code #3: 4114 - device not returned, results code: 3221 - no findings available, conclusions code: 4315 - cause not established.The affected sample was not returned; therefore, a thorough investigation could not be performed.A representative retention sample was reviewed with no visual damage, including the area of the venous thermister.All capiox units are 100% visually inspected at several points in the production process.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
 
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Brand Name
STERILE FX25REC W/RES
Type of Device
BLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
MDR Report Key10184115
MDR Text Key196085444
Report Number1124841-2020-00143
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450820
UDI-Public(01)00699753450820
Combination Product (y/n)N
PMA/PMN Number
K151791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2023
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberYD02
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/03/2020
Initial Date FDA Received06/23/2020
Supplement Dates Manufacturer Received07/16/2020
Supplement Dates FDA Received07/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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