MAUDE Adverse Event Report: EUROSETS S.R.L. ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number US5062

Device Problems Disconnection (1171); Improper Chemical Reaction (2952); Infusion or Flow Problem (2964)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

It was reported that while on the patient, the tubing at the oxygenator outlet came off and had to emergently be fixed.The tubing was connected past the 2nd barb and double zip-tied.The tubing used was verified to be a sorin custom pack with 3/8" x 3/32" tubing.The issue occurred approximately 2 hours after initiation of support and the tubing was replaced onto the outlet immediately, less than 5 seconds after it occurred.It was then double ty banded again and ensured tubing was past second barb again.The circuit used was cautiously double ty banded and past second barb, while the standard had been single ty band and past second barb.Prior to cannulation and prior to transport, it was ensured that ty bands were tight and tubing was secure past second barb per their safety checklist, and routine safety checks were done intratransport and post transport.There was no movement by staff or patient of the circuit or its components at time of disconnection.They had arrived at transport destination 20 minutes or so prior to the tubing disconnection.Transport went smoothly without incident or line tightness, etc., nothing of note that can be recalled.At the time the blood flow rate was 4.2 liters per minute and the pump speed was 3850 revolutions per minute (rpm).Pressures were not being monitored at the time as it was just after completion of a transport and transducers were hooked up after transport.With the same rpms and flow once transducers were hooked up an hour or so later, pre-oxygenator was approximately 230 mmhg and post oxygenator was approximately 170 mmhg.Patient did not experience any significant disruption in vital signs, stability, labs, etc.It was noted that the patient was on extracorporeal membrane oxygenation (ecmo) with centrimag and advanced membrane gas (amg) oxygenator.It was noted that rhinovirus was the only positive infectious test.Related manufacturer reference number: (b)(4) (centrimag blood pump).

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• Brand Name: ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE
• Type of Device: CONTROL, PUMP SPEED, 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: 18082993
• MDR Text Key: 327482300
• Report Number: 3003752502-2023-02403
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 08034013782020
• UDI-Public: 08034013782020
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US5062
• Device Lot Number: 009249208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American