MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR WEST ; BLOOD GAS OXYGENATOR

Model Number 3CXRX25RW

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corp.That, prior to cardiopulmonary bypass during prime, it was discovered that the water outlet port of the rx25 oxygenator was bent on the end.No pt involvement as this occurred during prime.Product was changed out.Surgery was completed successfully without delay.

Manufacturer Narrative

Terumo has received the actual device for eval; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more info becomes available.(b)(4).

Manufacturer Narrative

This f/u 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 (b)(6) 2015.The complaint was confirmed upon completion of the investigation.Visual inspection confirmed that the water outlet port was damaged; however, no additional damage was observed.A retention sample was visually inspected, and no anomalies were noted.A review of the device history record revealed no production related anomalies.The product is 100% visually inspected during manufacturing.The damage to the port was likely due to shock force post manufacturing; however, the cause of the damage is unknown.Because the plastic is thin at that point and appeared to be flattened, it can appear to look like melting.All available info has been placed on file in quality management for appropriate tracking, trending and f/u.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer Contact: robyn o'donnell, qlty mgnr ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4759497
• MDR Text Key: 18064587
• Report Number: 1124841-2015-00130
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor,company represent
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 3CXRX25RW
• Device Lot Number: RM27
• Other Device ID Number: (01) 00699753450110
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2014
• 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