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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 Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 05/11/2016
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, while the contents were being removed from the box, the arterial temperature connector was found to be loose inside the package. No patient involvement as this occurred out of box.
 
Manufacturer Narrative
The actual sample was not returned for evaluation; therefore, the complaint could not be confirmed and a definitive root cause could not be determined. A retention sample from the same product code/lot number combination was visually inspected and it was confirmed that both temperature probes, or thermistors, were securely attached to their intended ports and were not loose in the packaging. This product undergoes 100% visual inspection at several steps in the manufacturing process. It is likely that the product underwent damage during shipping and handling that caused the thermistor to break off of the port and be loose in the packaging. 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 Key5695112
MDR Text Key46416584
Report Number1124841-2016-00230
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 07/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberUC01
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 Received06/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2016
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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