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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR WEST BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*RX25RW
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
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 the purge line was missing the small white clamp, and the line was being clamped off by hemostats. A retention sample from the same product code/lot number combination was visually inspected and confirmed to have the white clamp present on the purge line. As the clamp is assembled between the vernay valve and the l-shaped connector, it would have to be placed onto the line during the purge line assembly process. The likely cause of the clamp missing from the line is that it had not been properly placed onto the purge line during assembly. A review of the device history record revealed no production related anomalies. (b)(4). All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the roberts clamp was missing from the recirculation line. No known impact or consequence to patient. Product was not changed out. Procedure was completed successfully.
 
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Brand NameCAPIOX RX25 OXYGENATOR WEST
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball rd
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball rd
elkton, MD 21921
8002837866
MDR Report Key6085795
MDR Text Key59462275
Report Number1124841-2016-00384
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 Other Health Care Professional
Type of Report Initial
Report Date 11/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model Number3CX*RX25RW
Device Catalogue NumberN/A
Device Lot NumberUH25
Other Device ID Number(01)00699753450110
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 Received10/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2016
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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