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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NON-STER X-COATED SX25 W/ RES; BLOOD GAS MONITOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NON-STER X-COATED SX25 W/ RES; BLOOD GAS MONITOR Back to Search Results
Model Number 3ZZSX25RX
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 10/05/2016
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, it was noticed that the female connection of the sampling line was frayed or broken.No patient involvement as this occurred during set up.Product was changed out.Procedure 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 october 25, 2016.Upon further investigation of the reported event, the following information is new and/or changed: (device availability), (date received by manufacturer), (indication that this is a follow-up report), (follow-up due to additional information), (device evaluation anticipated).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references (b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
Manufacturer Narrative
The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The returned sample was visually inspected, and it was found that the luer had been damaged and deformed.A pigtail from a retention sample was obtained.The cap was removed, and the luer was dipped into cyclohexanone.The cap was then reattached and the sample was left to sit overnight.The cap was then removed and the luer was deformed or damaged in a similar fashion to the returned sample.A retention sample from the same product code/lot number combination was visually inspected and the pigtail was confirmed to not be damaged as the returned sample had been.It is likely that during the assembly of the pigtail, a bonding agent had come into contact with the luer or cap, and then the cap had been assembled onto the luer, and this caused the deformation of the luer.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
 
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Brand Name
NON-STER X-COATED SX25 W/ RES
Type of Device
BLOOD GAS MONITOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball rd
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball rd
elkton, MD 21921
8002837866
MDR Report Key6055579
MDR Text Key58358585
Report Number1124841-2016-00364
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/19/2016
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 Date06/30/2019
Device Model Number3ZZSX25RX
Device Catalogue NumberN/A
Device Lot NumberUH25
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/06/2016
Initial Date FDA Received10/25/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/15/2016
12/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2016
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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