MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS, CORP. TERUMO CARDIOVASCULAR PROCEDURE KIT;; CARDIOVASCULAR PROCEDURE KIT- CONVENIENCE TUBING PACK

Model Number 70067-03

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No product has been returned at this time.For the specified model number upon documentation review no issues have been identified at this time.No lot number was provided.Due diligence attempts ongoing.(b)(4).

Event Description

It was reported "while on bypass, the cardiotomy reservoir was emptied and air was pumped through the bypass circuit and up to and possibly including the patient.After multiple attempts to gain additional information through the user facility perfusionist and risk manager, as of (b)(6) 2015 no clear details regarding the incident are known.All that is known is air was introduced into the cpb circuit.How the air was introduced is not known.It is not known if any air reached the patient.It is not known what mitigations were done by the clinical team to address the air.It is not known if the patient was harmed during these events.".

Manufacturer Narrative

(b)(4).As of november 19, 2015 no product has been returned.The user facility risk manager indicated there was no alleged product deficiency.No further diligence attempts will be performed.

Event Description

Per the clinical review on 29-oct-2015: the risk manager (rm) now states that the venous reservoir was drained accidentally during cardiopulmonary bypass procedure (cpb), but was not due to malfunction of system-1 or any other manufacturer product.The air never reached the patient, according to the rm, and there was no harm observed.The cpb would have been stopped and the air removed and then cpb would be re-initiated.This would delay the procedure, and a time off cpb of about two minutes is estimated.The procedure was completed successfully and no blood loss was reported.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Type of Device: CARDIOVASCULAR PROCEDURE KIT- CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS, CORP.; 28 howe street; ashland MA 01721
• Manufacturer Contact: jean burns ; 28 howe street; ashland, MA 01721 ; 5082312417
• MDR Report Key: 5188960
• MDR Text Key: 30323373
• Report Number: 1212122-2015-00014
• Device Sequence Number: 1
• Product Code: OEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 70067-03
• Other Device ID Number: (01)50699753460947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening; Required Intervention