MAUDE Adverse Event Report: SORIN GROUP ITALIA B-CAPTA 3/8 ARTERIAL CUVETTE; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Model Number 3/8" ARTERIAL CUVETTE

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/22/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures the b-capta sensor.The incident occurred in belgium.As per additional information provided, blood flow was 5l/min with line pressure of 300 mmhg at the time of failure.Blood dropped on the floor and poured out on the shoes of surgeon/ assistant/ perfusionist.Hlm was covered with blood too.The involved device has been requested for return to sorin group italia for investigation.The white cover ( holder protecting ) of the unit involved in this case reporting the serial number of the cuvette was thrown away.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group italia has received a report that, after 4 minutes having intiated a bypass, a leak was observed from the bcapta arterial cuvette 3/8.According to provided picutures, the leak was from the metal plate covering the membrane.Cuvette was changed out, blood loss was nearly one (1) liter and medical team elected to compensate it with 1l plasma expander.There is no report of any patient injury.

Manufacturer Narrative

According to follow up with the customer, the user promptly noticed the leak drop by drop but elected to continue without taking actions leading to a larger loss.This is in accordance with post market data confirming this issue is always detectable during priming/setup phase.Visual inspection of the returned sensor , with the help of advanced system viewer, found the metal clip was not hooked to the two clips on top area.Clips were integer and undamaged, thus excluding a molding defect as cause of the coupling failure.Subsequent leak test confirmed that defective mechanical connection of the clip with the pins was the site of leakage: fluid loss was reproduced as soon as liquid reached this area.Serial number of the cuvette reported on the white protective case was not specified (part not saved), therefore no verification of in-process leak test results could be performed.Based on b-capta assembly operations, the mechanical joint of metal clip to the sensor spot is performed by operator with a press tool; if subsequent visual check of newly assembled components is successfully passed, an air leak test is then executed to verify the integrity of the device.Taking into account investigation findings, the most likely root cause of complained leakage event from the middle of cuvette has been identified in incomplete mechanical joint / wrong subassembly of metal clip.Livanova has launched a dedicated capa project to identify adeguate containment and corrective actions.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: B-CAPTA 3/8 ARTERIAL CUVETTE
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (mo)
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17168653
• MDR Text Key: 317552291
• Report Number: 9680841-2023-00027
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 08033178113526
• UDI-Public: (01)08033178113526(17)251106(10)2211070204(240)05191
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K202154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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 Model Number: 3/8" ARTERIAL CUVETTE
• Device Catalogue Number: 05191
• Device Lot Number: 2211070204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2022
• 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