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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25RWC
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 11/09/2018
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 out of box, broken components was noted on the oxygenator reservoir. 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 29, 2018. (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 fda in accord with applicable regulations. (b)(4). The returned sample was visually inspected upon receipt. It was confirmed that oxygenator blood inlet port was broken off at the base of the oxygenator module. A retention sample from the same product code and lot number combination was visually inspected and found to have no damages or anomalies, specifically with 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 the ports of the oxygenator during shipping. It is likely that the 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. A review of the validations performed for the packaging of the capiox product was performed, finding that adequate validation testing has been performed. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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Brand NameSTERILE FX25RWC W/ RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
MDR Report Key8117663
MDR Text Key129047148
Report Number1124841-2018-00307
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K151791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model Number3CX*FX25RWC
Device Catalogue NumberN/A
Device Lot NumberWK27
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No

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