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

Model Number 3ZZ*RX25RW

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2017

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).Conclusion not yet available-evaluation in progress.

Event Description

The user facility report to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, there was a connector, on the oxygenator, that cracked and leaked.No know impact or consequence to patient; product was not 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 september 15, 2017.(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 ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on october 06, 2017.(b)(4).The returned sample was visually inspected.Evaluation of the returned sample found that the white connector was cracked on the vernay line along the connector body.Replication testing was performed which lead to the cracking along the part, in the same way as the returned sample.During setup of the circuit, the white connector had been over-tightened, causing it to crack.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS RX25RW OX W RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6870511
• MDR Text Key: 87305135
• Report Number: 1124841-2017-00190
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 3ZZ*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: VA02
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 09/19/2017; 10/25/2017
• Supplement Dates FDA Received: 10/06/2017; 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1