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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25RWC
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2022
Event Type  malfunction  
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the cardiotomy reservoir lid was not attached properly.*no patient involvement, *product was changed out, *procedure was completed successfully.
 
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).
 
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 august 30, 2022.Type of investigation #1: 10 - testing of actual/suspected device; type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer; type of investigation #3: 3331 - analysis of production records; investigation findings: 3259 - improper physical structure; investigation conclusions: 4307 - cause traced to component failure.The returned sample was inspected upon receipt to confirm a partially removed lid.The lugs were measured and found to be within specification.A representative retention sample was inspected to show that the lid was fully intact with no damage on the unit.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 FX25RWC W/ RES
Type of Device
BLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
Manufacturer (Section G)
SAME
Manufacturer Contact
jamie quinlan
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key15324334
MDR Text Key305423211
Report Number1124841-2022-00147
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450837
UDI-Public(01)00699753450837
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/23/2022
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*FX25RWC
Device Catalogue NumberN/A
Device Lot Number2D14
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/11/2022
Initial Date FDA Received08/30/2022
Supplement Dates Manufacturer Received09/21/2022
Supplement Dates FDA Received09/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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