MAUDE Adverse Event Report: EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number US5062

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thromboembolism (2654); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that when performing normal pigtail flushing following a lab draw, it was found to be extremely difficult to push back into the circuit. Clearly some form of obstruction, but did not seem as though there would be clot as the anticoagulation status was adequate, with no other visible signs of clots noted throughout the circuit. For fear of there being a clot, the process was discontinued. Without this finding communicated further, some days later, the nurse found that though there was resistance, the port flushed to the circuit. With a subsequent attempt a few hours later to do maintenance flushing by the same nurse, it was found that the port would again, not flush to the circuit. So there would be times when the valve would seem compromised in a way allowing the ability to flush to the circuit, and then at times, the integrity of the valve was recaptured and then did not allow for flushing. The plan was to possibly have the ecmo system removed soon, so the hope is to leave the device until removal, and will be shipped back to abbott. The patient has been extubated since on the device, and is seemingly doing quite well currently.

• Brand Name: ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• Manufacturer (Section G): EUROSETS S.R.L.; strada statale 12, n°143; medolla, modena 41036 ; IT 41036
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 10465936
• MDR Text Key: 231681542
• Report Number: 3003752502-2020-00072
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: US5062
• Device Catalogue Number: US5062
• Device Lot Number: 6013706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial