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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS RX25RW OX W RES BLOOD GAS OXYGENATOR

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS RX25RW OX W RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3ZZ*RX25RW
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 01/29/2018
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 11. (b)(4). Results: results pending completion of evaluation. Conclusions: conclusion not yet available-evaluation in progress.
 
Event Description
The user facility reported to terumo cardiovascular that the glue was coming apart at the one way valve. It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery. Due to the unknown information for this event, it is being reported. Terumo continues to attempt to gain more information regarding this event from the user facility.
 
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 february 16, 2018. (b)(4). The actual sample was not returned; therefore, a thorough investigation could not be performed and the actual root cause can not be determined. The provided picture was reviewed and confirmed the observation. The supplier of this part has been made aware of the issue and are reviewing their manufacturing process. All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
Event Description
Additional information was received indicating that, the event occurred during setup, the product was changed out, and the surgery completed successfully with no patient effect.
 
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Brand NameNS RX25RW OX W RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball road
elkton MD 21921
MDR Report Key7278666
MDR Text Key100512600
Report Number1124841-2018-00024
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 04/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model Number3ZZ*RX25RW
Device Catalogue NumberN/A
Device Lot NumberVL25
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

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