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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 Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 05/20/2016
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 the tape that closes the box needs to extend to the pull tab in order to open the box properly. The tape does not connect with the pull tab so they have to manually open the boxes. They are afraid that if they use a sharp instrument, they will compromise the sterility of the product inside the box. This event occurred during a non clinical activity; therefore, there was no patient involvement.
 
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 june 13, 2016. (b)(4). The actual sample was not returned for evaluation; therefore, the complaint was not confirmed. There was no specific lot identified to be affected by the reported issue; therefore, a review of the device history records could not be performed. The packaging process was reviewed and it was confirmed that the taping machine used for the outer boxes automatically meters out the correct length of tape; however, it must be properly adjusted in order to be correct. The length of tape on the box is not a functional issue, as it only affects how the packaging must be opened. All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
 
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Brand NameSTERILE FX25REC W/RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball rd
elkton MD 21911
Manufacturer Contact
shari bailey
125 blue ball rd
elkton, MD 21921
8002837866
MDR Report Key5720002
MDR Text Key47215019
Report Number1124841-2016-00240
Device Sequence Number1
Product Code DTZ
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Other Device ID Number(01)00699753450820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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