MAUDE Adverse Event Report: THORATEC CORPORATION STANDALONE PMP NEONATAL OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number US5088

Device Problems Disconnection (1171); Device Difficult to Setup or Prepare (1487)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

Section a patient information requested.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that there was a pigtail disconnected from the oxygenator during an extracorporeal membrane oxygenation (ecmo) run on (b)(6) 2023 around 0800.The pigtail was attached to oxygenator's luer connector at the bottom.The lines were immediately clamped, and the pigtail was replaced.The patient remained on ecmo support, and the system operated properly.A replacement pigtail was used.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the report of a pigtail tubing disconnection from the blood inlet luer of the oxygenator could not be conclusively determined through this evaluation; however, the supplier of the oxygenator (eurosets) determined that there was no fault of the device and no correlation between the event and the oxygenator.The oxygenator was returned to abbott where an initial visual inspection was performed.Pigtail tubing was connected to the blood inlet luer port, and no obvious damage was noted to the luer port upon removal of the pigtail tubing.Visual inspection of the remainder of the oxygenator revealed no obvious damage.The returned pigtail tubing was able to be disconnected and securely reconnected to the blood inlet luer port without any apparent issues.The device history record for the eurosets amg pmp infant oxygenator, serial #8568400, was reviewed by the external manufacturer (eurosets) and showed that all tests from the production process were compliant with the technical specifications.Eurosets did not provide this oxygenator with the tubing already assembled.The available information indicates that after the tubing was replaced, there were no more problems.Eurosets noted that if there had been any damage on the oxygenator, another tubing would have had the same problem.Eurosets determined that there was no fault of the oxygenator and no correlation between the event and the oxygenator.The production documentation for the eurosets amg pmp infant oxygenator, serial # (b)(6), was reviewed by the external manufacturer (eurosets) and showed that all tests made in the production process were compliant with the technical specifications.The eurosets amg pmp infant cardiopulmonary bypass oxygenator instructions for use (ifu), rev.00, is currently available.Under the list of warnings, the ifu warns that the device is intended to be used by professionally trained personnel.The extracorporeal circulation has to be carefully and continuously checked by qualified healthcare professionals throughout the procedure.The ifu warns to carefully check the device seal during priming and operation.Under the section titled ¿set up¿, the ifu instructs to check that all connections are properly secured, closed, or fastened.The detachment of unsecured tube connections can lead to blood loss and air embolism in the patient.Tighten the connections to the oxygenator if necessary.Under the section titled ¿during bypass¿, the ifu instructs that during the entire procedure, according to good prefusion practices, monitor the integrity of the system for leaks absence.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: STANDALONE PMP NEONATAL OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 17997531
• MDR Text Key: 326415810
• Report Number: 3003752502-2023-02401
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 8034013782020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: US5088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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