MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SX OXYGENATOR W/HR (STERILE); BLOOD GAS OXYGENATOR

Model Number 3CXSX25R

Device Problems Break (1069); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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 code: results pending completion of evaluation.Conclusions code: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the water line arm was cracking and breaking off.No patient involvement.Product was changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.The returned sample was visually inspected.It was found that 5 of the 6 heat exchanged water port l-tubes were broken off.Additionally, scuff marks were noted on each returned he housing.A retention sample from the same product code/lot number combination was visually inspected and no anomalies were noted.It is likely that the units were exposed to damage after manufacturing that caused the water tubes to break.It was not able to be determined how or when the damage occurred.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SX OXYGENATOR W/HR (STERILE)
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7006233
• MDR Text Key: 92200714
• Report Number: 1124841-2017-00232
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

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: 09/30/2019
• Device Model Number: 3CXSX25R
• Device Catalogue Number: N/A
• Device Lot Number: UM03
• Other Device ID Number: (01)00699753450073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2016
• 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