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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RWC W/ 3L RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RWC W/ 3L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RW30C
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 05/03/2017
Event Type  malfunction  
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 may 24, 2017. Upon reviewing the device history records and electronic tracking of the affected product, no anomalies were noted. Without the product coming back to tcvs (b)(4) prior to shipment to the customer, the packaging was not able to be visually inspected to ensure no damage or anomalies. It is possible that between shipments, an issue occurred where product had been removed from the outer case, causing the case to be missing the two units; however, this was not able to be confirmed. It was attempted to receive the weights of the products upon shipping in order to confirm that all of the product had been present in the cases when they left the dc; however, they were not able to be obtained. The remaining product was reconciled. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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 during out of box, one of the cases received lacks two items. No patient involvement as this occurred during out of box.
 
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Brand NameSTERILE FX15RWC W/ 3L RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key6589961
MDR Text Key192891697
Report Number1124841-2017-00092
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/29/2020
Device Model Number3CX*FX15RW30C
Device Catalogue NumberN/A
Device Lot NumberVD13
Other Device ID Number(01)00699753450783
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2017
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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