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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 11/07/2018
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. For this reason, terumo references evaluation conclusion code. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during out of box, the line that is attached to one side of the manifold was shred off. 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 nov 24, 2018. (b)(4). The sample was not returned for evaluation. A retention sample from the same product code and lot number was inspected and there was no damage anywhere on the device, specifically on the manifold line. All reservoirs are 100% visually inspected at several points in the production process. The packaging of the product also ensures protection against damage to any caps on the reservoir. It is likely that the cap 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 Key8100188
MDR Text Key128275465
Report Number1124841-2018-00301
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 01/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model Number3CX*RX25RW
Device Catalogue NumberN/A
Device Lot NumberWH16
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/09/2019
Is This a Reprocessed and Reused Single-Use Device? No

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