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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*FX25REC
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 10/05/2016
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 customer reported to terumo cardiovascular that the account should of received a case of item (b)(4), instead they received a case of (b)(4) which is the incorrect item. The outer box and the product show that the incorrect item was shipped. 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 october 27, 2016. Upon further investigation of the reported event, the following information is new and/or changed: (device availability), (date received by manufacturer), (indication that this is a follow-up report), (follow-up due to additional information), (device evaluation anticipated). A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references (b)(4). All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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. (b)(4). The sample was returned for evaluation. The shipping of this product was traced in order to determine how the incorrect product had been placed into the outer box. It was found that a separate customer had originally received the product 3cx*rx25re in error. At this time, the customer must have removed the incorrect rx product, and placed it into an fx25 outer box. This box with the rx product was returned to the (b)(4) distribution center. The (b)(4) received the returned product as 3cx*fx25re uh11, as this is what the outer box stated, and noted in the system that the incorrect product was returned, and rx25 product should have been returned, without opening the outer box to confirm the one-piece boxes within. The returned product was placed back into inventory as fx product, and then was shipped out to the reporting customer. That is when the customer opened the outer fx box and discovered that rx25 product was shipped within the outer box. 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 Key6062043
MDR Text Key58604116
Report Number1124841-2016-00366
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 distributor,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2019
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberUH11
Other Device ID Number(01)00699753450820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2016
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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