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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR WEST BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR WEST BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*RX25RW
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 12/08/2016
Event Type  malfunction  
Manufacturer Narrative
Terumo has not received the actual device; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow- up report when the investigation is complete and more information becomes available. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, a dead cricket was found inside the "egg crate" carton but outside of the sterile packaging of the oxygenator. The customer believes the cricket climbed into box at some point during transit or at a warehouse through perforated (open) handhold on box. *no patient involvement, as the event occurred during set up. *the 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 december 19, 2016. The actual device was not returned for evaluation; however a photograph of the event was provided by the user facility. Upon inspection of the provided photo, it was confirmed that there was a cricket within the packaging of the product. A retention sample from the same product code/ lot number combination was visually inspected and no foreign matter was found within the packaging. Based on information received from the customer, it is likely that the cricket entered the packaging through the handle hole in the box. All packaging is 100% visually inspected in-process. When or how the cricket entered the packaging was not able to be confirmed. Review of the device history records revealed no manufacturing issues. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand NameCAPIOX RX25 OXYGENATOR WEST
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 Key6186290
MDR Text Key62752548
Report Number1124841-2016-00430
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130333
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model Number3CX*RX25RW
Device Catalogue NumberN/A
Device Lot NumberUD28
Other Device ID Number(01)00699753450110
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 Received01/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2016
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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