MAUDE Adverse Event Report: LIVANOVA USA INC SMART PERFUSION PACKS; SMART, PERFUSION PACKS, CONNECTORS, TUBING

Catalog Number 044005300

Device Problem Material Puncture/Hole (1504)

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

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

Device available for evaluation the tubing has been received on 01 september 2022.Sorin group italia manufactures the smart perfusion packs.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.During follow up with the customer it was clarified that the pump in use was a competitor pump, no raceway failure was observed, the pump occlusion was adequate.No other similar event has occurred.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Livanova usa has received a report that, prior to going on bypass, the yellow pump suction in the raceway ruptured.The issues occurred when the suction line was on about 10 minutes.No blood loss occurred.There is no report of any patient injury.

Manufacturer Narrative

Livanova received a report that, prior to going on bypass, the yellow pump suction line in the raceway ruptured.The customer has provided a video showing the complained issue.No report of any patient injury.Involved item returned to arvada for investigation.Visual inspection confirmed the tubing rupture.The length of the rupture was approximately 8".No issues with the tubing dimensions could be found in the manufacturing data of the tubing supplier.The was confirmed to be within livanova specification with no evidence of manufacturing deviation.Manufacturing records have been verified to be conforming to specifications.No other similar events have been identified for this circuit item code.The most likely root cause of the reported event is a sharp edges or foreign material in the competitor pump raceway.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

Event Description

See inital report.

Manufacturer Narrative

The complained tubing was inspected at livanova usa and reported condition was confirmed on the returned sample; the tubing was split as called out by the customer.No issues with the tubing dimensions could be found.Cpk data provided by tubing supplier does not indicate any sort of irregularity regarding inner diameter for this lot number of tubing.There were no irregularities in the wall thickness observed on the tubing sections directly on either side of the rupture.Root cause of this issue remains unclear.Possible root causes to be evaluated are settings on the roller pump or a weak spot in the tubing.

• Brand Name: SMART PERFUSION PACKS
• Type of Device: SMART, PERFUSION PACKS, CONNECTORS, TUBING
• 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: 15376754
• MDR Text Key: 305793213
• Report Number: 1718850-2022-00051
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 0803622113376
• UDI-Public: (01)0803622113376(240)044005300(17)240731(10)2220000107
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 044005300
• Device Lot Number: 2220000107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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