MAUDE Adverse Event Report: MEDTRONIC MEXICO MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE; DEFOAMER, CARDIOPULMONARY BYPASS

Model Number VRV-100

Device Problem Obstruction of Flow (2423)

Patient Problem Swelling/ Edema (4577)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

The vrv-100 is a class two exempt device and it does not have a 510(k) number.The vrv was part of the following custom tubing pack: model number: bb9q36r3, lot number: 222374725.The following vrv lots were used in this custom tubing pack; 222176653, 222176654 and 222176655.The manufacturing dates for the lots are as follows.Lot: 222176654 manufacturing date: 10 may 2021, lot: 222176655 manufacturing date: 11 may 2021, lot 222176653 manufacturing dates: 10 may 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a custom tubing pack for a coronary artery bypass grafting (cabg) procedure, the customer reported that the one way valve (vrv) on the root vent line was malfunctioning. shortly after initiating bypass it was noticed that the root line was full and was struggling to empty the aortic root despite both manipulation of the root cannula and an increase in the amount of suction.After examination of the valve there was a deformity noted with one of the two small black ¿plunger/stoppers¿.The valve was replaced to complete the procedure.The patient had cardiac distention prior to changing out the vrv.Once the vrv was changed out, there was good aortic root drainage allowing for the heart to decompress.There were no long term affects to patient.Additional information: the valve was initially tested with plasmalyte when lines were attached to the table and was working properly as verified by both the sales rep and the surgical technician. after switching out the malfunctioning valve for a new valve, full function of the aorta vent was restored and functioned normal throughout the entirety of the case.The health care professional (hcp) seemed to think that the black flexible stopper inside looked dislodged or collapsed down.

• Brand Name: MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
• Type of Device: DEFOAMER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13575730
• MDR Text Key: 286647817
• Report Number: 9612164-2022-00712
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2023
• Device Model Number: VRV-100
• Device Catalogue Number: VRV-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/22/2022
• 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): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 116 KG