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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 05/12/2016
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). Conclusions: conclusion not yet available-evaluation in progress.
 
Event Description
The distribution facility reported to terumo cardiovascular that the plastic skids the product is being shipped on, are breaking and causing damage to the outer packaging of the product. The plastic appears to be brittle, they are cracked, split, and have broken sections that are separated from the pallet resulting in sharp edges. This event occurred at a distribution facility; therefore, there has been 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 3, 2016. (b)(4). The actual device was not returned for evaluation; however a photograph of the event was provided. Inspection of the photos confirmed the broken skids and damaged product. A review of the device history record revealed no anomalies. The cause of the event is the use of plastic skids rather than wooden pallets. 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 21921
Manufacturer Contact
shari bailey
125 blue ball rd
elkton, MD 21921
8002837866
MDR Report Key5697040
MDR Text Key46493967
Report Number1124841-2016-00239
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 distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberUE11
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 Received08/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2016
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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