MAUDE Adverse Event Report: LIVANOVA USA, INC COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number 627417401

Device Problem Misassembled (1398)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

The involved device is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.The present mfr report number was submitted on january 15, 2020 as mfr report number 1718850-2020-00001.The first and second acks were successfully processed (core id: (b)(4)).The third ack failed as it contained the error message that there was duplicate report.Investigation confirmed that the report number 1718850-2020-00001 was indeed a duplicate due to an error while creating an importer report number.To avoid reoccurrence, the relevant personal has been retrained on the procedure for importer report submission and the present report has been submitted with a different mfr report number (1718850-2020-00015).

Event Description

Livanova usa inc has been informed that the color codes that enables to discriminate blood or cardioplegia delivery solution in a cardioplegia set were swapped.During a procedure, the perfusionist has inadvertently clamped one of the two lines and air was cavitated into the cardioplegia set.The presence of air in the set was identified and the issue rectified.There is not report of any patient injury.

Manufacturer Narrative

The reported issue was that the color-coded clamps, indicating which lines for the user to operate during a procedure, were misplaced on the bridges of the cardioplegia line.The device was not made available for investigation.The customer has provided photographic evidences confirming the clamps were misplaced.A review of the dhr did not identify any issue possibly related to the reported issue.No other similar complaint was received for the claimed lot.The investigation confirmed the reported failure.Livanova believes the most probable root cause was a human error during manual assembly steps.Frequency of occurrence of this type of event is low.To prevent possible re-occurrence, manufacturing operators will be retrained.Livanova will keep monitoring the market.The present mfr report number was submitted on (b)(6)2020 as mfr report number 1718850-2020-00001 follow up 1.The first and second acks were successfully processed (coreid: ci1582215738399.260299@fdsuv08651_te1).The third ack failed as it contained the error message that there was duplicate report.Investigation confirmed that the report number 1718850-2020-00001 was indeed a duplicate due to an error while creating an importer report number.To avoid reoccurrence, the relevant personal has been retrained on the procedure for importer report submission and the present report has been submitted with a different mfr report number (b)(4).

• Brand Name: COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC; 14401 w.65th way; arvada, co
• MDR Report Key: 9989292
• MDR Text Key: 191197210
• Report Number: 1718850-2020-00015
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 0080322144431
• UDI-Public: (01)0080322144431(240)627417401(17)211130(10)1931900068
• Combination Product (y/n): N
• PMA/PMN Number: K881330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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 Expiration Date: 11/30/2021
• Device Catalogue Number: 627417401
• Device Lot Number: 1931900068
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1