MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH STOCKERT SCPC; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 60-03-75

Device Problems False Alarm (1013); Mechanical Problem (1384); No Flow (2991); Air/Gas in Device (4062)

Patient Problems Cardiac Arrest (1762); Irritability (2421); Low Oxygen Saturation (2477); Sleep Dysfunction (2517); Respiratory Arrest (4461); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/05/2022

Event Type  malfunction  

Event Description

Emergency code response to unresponsive patient and possible extracorporeal membrane oxygenation (ecmo) circuit emergency.Patient on va ecmo for pulmonary hypertension (phtn) listed and delisted for heart/lung transplant during her course of ecmo run.Ecmo cannulas placed in right internal jugular (rij) and right common carotid artery (rcca).She is active and verbal.She refuses neck collar while in bed.She seems agitated in the last couple of days and hasn't been able to sleep.She had two prior circuit events which she required a part of her circuit replaced once and a whole circuit change for the second event both related to air bubble alarm that has interrupted forward flow.On both events, no circuit air were noted by ecmo specialists.Bedside rn had noted dampening of blood pressure tracing and while adjusting arterial line position on her wrist, she found patient unresponsive.Ecmo specialists, at the same time during her hourly circuit assessment and cannula check noticed patient unresponsive as well.This had occurred after patient had turned to her right side (cannula side).They activated code at that time.Team responded to emergency code.Perfusionist assessed the circuit, there is no air noted at this time.There is no flow reading at this time.Preceded with hand cranking due to what presented itself as mechanical failure.Maintained ecmo flows at 2 l/min to support bp and oxygenation.Perfusionist noted micro air collection in oxygenator both post and pre-sides.No air was noted on the arterial limb of the circuit.Evacuated 2 cc if air from post oxygenator side.Yellow vent cap was taken off to assist the micro air removal from pre oxygenator side.Md was notified about the micro bubbles in the circuit.Patient was taken off the support.We preceded with circuit change.Clear primed circuit was used to reestablish ecmo flow.Bedside head computed tomography (ct) was ordered.There were no connections on the negative side of the circuit but the venous cannula.Micro bubbles are suspected to be from patient cannula position and potential kink with cavitation.Summary: patient awake initially, speaking to provider 20 minutes prior to event, patient is ambulatory.Noted her bp tracing dampened, assessment she found unresponsive and limp up, ecmo rn then assessed patient for hourly check and assessed as limp, code called, perfusion and providers to bedside ,perfusion noted monitor quiet, no air in circuit initiated hand-cranking noted air on top of pre-oxy side of oxygenator and air on top of post oxi-side.Air evacuated, no air noted at distal part of oxygenator or arterial limb and then proceeded with circuit change.There was minimal temporary harm.Device is currently in perfusionist office, taken out of use.

• Brand Name: STOCKERT SCPC
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 15275422
• MDR Text Key: 298405536
• Report Number: 15275422
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 60-03-75
• Device Catalogue Number: 60-03-75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2022
• Date Report to Manufacturer: 08/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Sex: Female