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

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.

• Brand Name: NS RX25RW OX W RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7278666
• MDR Text Key: 100512600
• Report Number: 1124841-2018-00024
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 3ZZ*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: VL25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1