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

Model Number 3CX*RX25RE

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

The user facility reported to terumo cardiovascular systems corp that, out of box, an irregular hole was discovered in the cap on the blood-in port.The cap was removed and the inlet was found to be deformed.No patient involvement as this occurred out of box.

Manufacturer Narrative

Terumo has received the actual device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a f/u report when the investigation is complete and more info becomes available.For this reason, terumo references evaluation conclusion code.(b)(4).

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations and as indicated by terumo cardiovascular systems ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on may 20, 2015.(b)(4).The actual device was visually inspected upon receipt, and the reported damage was confirmed.Damage was observed on the blood inlet port cap and corresponding damage was observed on the blood inlet port.Additional minor damage was observed on the gas outlet cap, consistent with both caps being damaged at the same time and consistent with shock force.A review of the device history record revealed no anomalies.A retention sample from the same lot was inspected and no damage was observed.The root cause of the damage has been attributed to shock force when the unit was outside of the box.(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 the fda in accord with applicable regulations and as indicated by terumo cardiovascular systems.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• 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 ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4791546
• MDR Text Key: 15966823
• Report Number: 1124841-2015-00172
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2015

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: 3CX*RX25RE
• Device Lot Number: TA19
• Other Device ID Number: (01)00699753450103
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/29/2015
• Initial Date FDA Received: 05/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/28/2015; 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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