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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 Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 09/06/2018
Event Type  malfunction  
Manufacturer Narrative
Terumo has not received the 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 when more information becomes available. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, when the oxygenator was pulled out from the package the inlet port broke off. No patient involvement as this occurred during setup. 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 october 2, 2018. (b)(4). The returned sample was visually inspected and it was confirmed to have damage to the blood inlet port. A retention sample from the same product code and lot number combination was inspected and there was no damage anywhere on the device, specifically none to the blood inlet port on the oxygenator. All oxygenators are 100% visually inspected at several points in the production process. The packaging of the product also ensures protection against damage to any ports of the oxygenator. It is likely that the blood inlet port was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined. 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 CORPORATION
125 blue ball road
elkton MD 21921
MDR Report Key7928109
MDR Text Key122457704
Report Number1124841-2018-00244
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K153213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model Number3CX*RX25RW
Device Catalogue NumberN/A
Device Lot NumberWE02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

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