MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION PRESCRIPTIVE OXY PACK - CAPIOX; BLOOD GAS OXYGENATOR

Model Number 74283

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2017

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.For this reason, terumo references evaluation conclusion code.(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 procedure, during prime, the prescriptive oxy was leaking at the temp probe connection.No patient involvement as this occurred during prime.Product was 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 december 20, 2017 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.The returned sample was visually inspected.It was confirmed that the oxygenator leaked at the connection point of the temperature probe.Oxygenators are 100% leak tested in process, which would detect any similar cracks on the ports; therefore, the crack in the part did not exist during the manufacturing process.The returned sample was then pressure tested; it was primed with water then pressurized manually with a syringe.At approximately 150 mmhg, water was seen dripping from the connection point of the thermistor (temperature probe) to the blood outlet port of the oxygenator.It is likely that an extreme force was exerted on the port/thermistor at some point during shipping and handling causing the part to crack, leading to a leak during prime.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: PRESCRIPTIVE OXY PACK - CAPIOX
• 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: 7136884
• MDR Text Key: 95834833
• Report Number: 1124841-2017-00256
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 02/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 74283
• Device Catalogue Number: N/A
• Device Lot Number: VK21A
• Other Device ID Number: (01)00699753487680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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