MAUDE Adverse Event Report: SORIN GROUP USA, INC CUSTOM PERFUSION TUBING SET; CARDIOVASCULAR PROCEDURE KIT

Catalog Number 044003500

Device Problem No Flow (2991)

Patient Problems Seizures (2063); Ventilator Dependent (2395); Patient Problem/Medical Problem (2688)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

Patient identifier was not provided.Patient age was not provided.As it is not yet known which device, if any, within the custom perfusion tubing set malfunctioned, the 510(k) number is not yet known.This information will be provided if and when it becomes available.Through follow-up communication with the customer, sorin group usa was informed that the reported alarm was a false alarm and could not be cleared.The customer was unable to reestablish flow by turning off level alarm module and removing the arterial clamp from the line.The customer then attempted to use hand cranks to reestablish flow, but was unable to do so.The entire disposable circuit and level sensor had to be switched out to reestablish flow complete the procedure.The customer reported that the patient was responsive in the recovery unit.During additional communication, sorin group usa learned that the patient has experienced seizures following the procedure.The customer stated that the patient has experienced epileptic seizures in the past, but not for about 20 years.The latest information from the facility is that the patient is still on a ventilator and responds to sound.The level of permanent impairment has not yet been determined.The involved disposable custom perfusion tubing set has been sent to sorin group usa for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Not yet returned to manufacturer.

Event Description

Sorin group usa received a report that a level alarm occurred during a procedure causing the arterial remote clamp to close.The user was able to reestablish flow after replacing the entire disposables circuit with a circuit from a new customer perfusion tubing set.The facility reported that the patient was off pump for 10-15 minutes during this event and had to be placed on a ventilator following the procedure.

Manufacturer Narrative

On march 3, 2017, (b)(4) received a user medwatch report related to this event.No additional information was included in the report.

Manufacturer Narrative

The tubing set was returned to livanova for evaluation.However, due to on-going litigation the affected tubing set was requested for return back to the customer without an investigation being performed.No further evaluation can be performed at this time.Returned to customer due to litigation.

Manufacturer Narrative

After further follow-up communication with the customer, the product was eventually returned to livanova usa again for investigation.Visual inspection of the product identified that the pre-bypass filter was soaked with blood along the filter.The product was tested using both a normal pump and a hand crank, which revealed that the revolution pump head functioned exactly as expected, with no non-conformities detected during simulated use.As the reported issue could not be reproduced, a root cause could not be determined.Based on the event description and the results of evaluation, it cannot be confirmed that a product malfunction occurred.

• Brand Name: CUSTOM PERFUSION TUBING SET
• Type of Device: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): SORIN GROUP USA, INC; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6376487
• MDR Text Key: 69014770
• Report Number: 1718850-2017-00001
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 0803622129162
• UDI-Public: (01)0803622129162(240)044003500(17)180930(10)1627000047
• 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
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 044003500
• Device Lot Number: 1627000047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Weight: 74