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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 3L RES; BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 3L RES; BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RE30C
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 08/24/2020
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).
 
Event Description
The user facility reported to terumo cardiovascular that there was a broken inlet line on the entrance to the oxygenator.Additionally, the perfusionist identified that this occurred because the box created pressure of the paper barrier in the package directly on this line.It is unknown when this event occurred, 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 september 11, 2020.G4 (date received by manufacturer).G7 (indication that this is a follow-up report).Additional information was received from the subsidiary regarding this event.It was determined that this event is not a malfunction of the actual device.The reported event was due to the repacking of the device at the subsidiary.There will be no additional follow ups submitted regarding this event.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 FX15REC W/ 3L RES
Type of Device
BLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
MDR Report Key10521854
MDR Text Key207580666
Report Number1124841-2020-00219
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450806
UDI-Public(01)00699753450806
Combination Product (y/n)N
PMA/PMN Number
K151389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/15/2020
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 Model Number3CX*FX15RE30C
Device Catalogue NumberN/A
Device Lot NumberXP02
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/25/2020
Initial Date FDA Received09/11/2020
Supplement Dates Manufacturer Received09/14/2020
Supplement Dates FDA Received09/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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