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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 Infusion or Flow Problem (2964)
Patient Problem No Patient Involvement (2645)
Event Date 04/28/2020
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 prior to cardiopulmonary bypass, during prime, they noticed air bubbles occurring and rising at the venous inlet.Per user facility, they tightened all connections but wasn't able to stop the bubbles.No patient involvement.The product was changed out.The surgery was completed successfully.
 
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 may 18, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 3259, 25) method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 3259 - improper physical structure.Conclusions code: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt with no anomalies noted.It was disassembled where it was found that the small o-ring had been incorrectly installed, allowing the air leak to occur.A representative retention sample was inspected and tested to confirm an appropriately seated o-ring.The retention sample was setup in a water circuit with flow through the unit, when forward flow was stopped, prime was not lost in the circuit.The cause of the event is a partially seated o-ring within the curved venous inlet port connection into the venous reservoir lid/housing.The o-ring creates an air-tight seal.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 Key10067571
MDR Text Key200842456
Report Number1124841-2020-00118
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,foreig
Type of Report Initial,Followup
Report Date 06/23/2020
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 Date09/30/2022
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberXM21
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/28/2020
Initial Date FDA Received05/18/2020
Supplement Dates Manufacturer Received06/18/2020
Supplement Dates FDA Received06/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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