MAUDE Adverse Event Report: LIVANOVA USA INC SMART TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 627368401

Device Problem Component Misassembled (4004)

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

Event Date 04/01/2022

Event Type  malfunction  

Manufacturer Narrative

Patient id, age, gender, weight and ethnicity: no patient information has been provided.Livanova usa inc manufactures the complained circuit.The incident occurred in (b)(6).Follow up with the customer clarified that there is only one unit affected by the mis-assembly.In detail, the red and blue tapes were opposite at the connectors as they were at the soft y, so what the surgeon thought was the red line back at the pump, the perfusionist thought it was the blue line.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova usa inc has received a report that, after a few times of trying to give cardioplegia and not being successful and the surgeon noticed that the red and blue tapes were not the same on opposite ends of the tubing.Once discovered they were able to work things out and complete the procedure.There is no report of any patient injury.

Event Description

See intial report.

Manufacturer Narrative

The complained device has been received at livanova usa.Initial visual inspection confirmed the reported condition: two of the red and blue tapes were switched on the two legs.Per drawing for 627368401, one leg is supposed to have 2 red tapes on one leg, and 2 blue tapes on the other leg.However, each leg had one red and one blue tape.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See intial report.

Manufacturer Narrative

Livanova received a report stating that, during procedure, no cardioplegia could be administered due to misassembly.No patient/user affected.The complained unit was returned to livanova for investigation.Visual inspection confirmed the reported condition: two of the red and blue tapes were switched on the two legs.Per relevant technical documentation, one leg is supposed to have 2 red tapes on one leg, and 2 blue tapes on the other leg.However, each leg had one red and one blue tape.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.By reviewing the complaints database, no further similar event has been recorded on this pts pack code.Based on above, most likely the root cause was due to a manufacturing operator error during the assembly phase of this pts and then he didn't follow tape down.To prevent reoccurrence, the capa-arv-2022-0003 was initiated.The risk is in the acceptable region.No other corrective action is deemed necessary.Livanova will keep monitoring the market.

• Brand Name: SMART TUBING AND CONNECTORS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 14166757
• MDR Text Key: 289740184
• Report Number: 1718850-2022-00035
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622133671
• UDI-Public: (01)00803622133671(240)627368401(17)240131(10)2201900053
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981613
• 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,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 627368401
• Device Lot Number: 2201900053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2022
• 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