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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEM CORP. CAPIOX RX25 OXYGENATOR WEST BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*RX25RW
Device Problems Device Damaged Prior to Use (2284); Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 10/18/2016
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 while the product was being removed from the box, the inlet connector of the oxygenator was discovered to be broken. 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 november 7, 2016. (b)(4). The sample was not returned for evaluation. A retention sample from the same product code/lot number combination was visually inspected and confirmed to not have any damages or anomalies, specifically with the inlet and outlet ports. A review of the device history record revealed no manufacturing anomalies. A definitive root cause could not be determined; therefore, this complaint is not confirmed. 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 SYSTEM CORP.
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key6080908
MDR Text Key59337104
Report Number1124841-2016-00382
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 12/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2016
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 Received12/08/2016
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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