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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR EAST BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*RX25RE
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 01/16/2017
Event Type  malfunction  
Manufacturer Narrative
Terumo has received the actual 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 more information becomes available. For this reason, terumo referenced evaluation (b)(4). (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular systems that during out of box, customer received an oxygenator with a sterilization tag on the box that says product awaiting eto sterilization. Customer believes that the product has not been sterilized yet. No patient involvement as this occurred out of box.
 
Manufacturer Narrative
This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on february 1, 2017. Method: actual device evaluated; visual inspection; storage and shipment review. Results: shipping problem. Conclusions: human factors issue. The returned sample was visually inspected, during which it was found that a sterilization tag was still present on the outer carton. The shipment of this product was traced and it was determined that the carton was sent to sterilization from (b)(4) after manufacturing, with the sterilization tag present. After sterilization, the product was sent directly to the distribution center in tennessee, where the tag was not removed. The product was then delivered to the customer with the tag still remaining on the carton. When the product was shipped from sterilization to the distribution center directly, the awaiting sterilization tag should have been removed by an associate prior to shipping to the customer. 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 EAST
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 Key6294958
MDR Text Key66318381
Report Number1124841-2017-00010
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153213
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 02/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model Number3CX*RX25RE
Device Catalogue NumberN/A
Device Lot NumberUN07
Other Device ID Number(01)00699753450103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2016
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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