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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25RE OX W/ RES ; BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX25RE OX W/ RES ; BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25RW
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 03/27/2015
Event Type  malfunction  
Event Description
The user facility reported to terumo cardiovascular systems corp that out of the box it was discovered that the manifold and pressure lines were missing.No pt involvement as this occurred out of the box.The procedure was not delayed.
 
Manufacturer Narrative
Terumo has received the actual device for eval; however, the investigation has yet to be completed.Terumo plans on submitted a follow up report when the investigation is complete and more info becomes available.For this reason, terumo referenced eval conclusion.(b)(4).
 
Manufacturer Narrative
This f/u report is submitted to fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on april 14, 2015.Upon evaluation of the device, the complaint was confirmed.Visual inspection confirmed that the sampling manifold was missing.Magnified inspection revealed that there was a scuff mark on the slot in the reservoir lid where the sampling manifold is inserted.This indicates that a sampling manifold was most likely installed on the reservoir during manufacturing.A retention sample was visually inspected, and the sampling manifold was present.A review of the device history record revealed no production related anomalies.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 FX25RE OX W/ RES
Type of Device
BLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball rd.
elkton MD 21921
Manufacturer (Section G)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball rd.
elkton MD 21921
Manufacturer Contact
robyn o'donnell, quality mgr
125 blue ball rd.
elkton, MD 21921
8002623304
MDR Report Key4698413
MDR Text Key20460249
Report Number1124841-2015-00094
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,Distributor,company represent
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/27/2015
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 Date11/30/2017
Device Model Number3CX*FX25RW
Device Lot NumberRP01C
Other Device ID Number(01)00699753450479
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/02/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Device Age4 MO
Event Location Hospital
Initial Date Manufacturer Received 03/27/2015
Initial Date FDA Received04/14/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/08/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2014
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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