MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number MCP00706291#ROTAFLOW PUMP MODULE

Device Problems Pumping Stopped (1503); Battery Problem (2885)

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

Event Date 02/19/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in (b)(6).It was reported that a patient was admitted to the (b)(6) (hospital name) on (b)(6) 2022 due to repeated coughing, expectoration and dyspnea for more than a month.On (b)(6) due to the continuous increase in respiratory parameters, the patient's condition did not improve.Vvecmo treatment was performed after multiple communication.On (b)(6) the family asked the hospital to be transferred the patient to (b)(6).When passing the bed at around 10:00 o´clock, the ecmo power cord was loose, the machine immediately went black and stopped running.The patient's blood oxygen saturation po2 dropped to 85%, immediately increase the breathing parameters, activate the ecmo hand crank and restarted ecmo after connecting to the power supply.After stabilizing the patient and all the preparations before the transfer, unplug the ecmo power cord, the ecmo can run normally, the battery voltage shows 21.6v, during the process of escorting the patient to the emergency 120 car (ambulance), the machine alarm prompts low voltage, and then the machine goes black and stops running again.The patient's po2 dropped to 80%, and emergency treatment was carried out immediately.After stabilization, the 120 car was connected to the power supply immediately.After arriving at the (b)(6), the power was unplugged, the voltage displayed 23v, and the patient was successfully escorted to the icu of (b)(6).After the incident was treated urgently, the patient's vital signs were stable.According to the telephone communication between the operator and getinge field service technician this rotaflow console is a device produced in (b)(6) 2018, and the battery has not been replaced since the installation.After disconnecting the ac power, the displayed voltage is 21.6v, which is already a low voltage, and the battery's power storage capacity is low.The customer was advised that the service manual state that the battery needs to be replaced every two years or if the battery cannot be fully charged within 8.5 hours, or if the battery cannot be fully charged and cannot keep the system running for 30 minutes.At present, the customer is aware of the battery problem.The cause of the occurrence is known, and the battery is being ordered for replacement.The patient's vital signs were stable.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in china.It was reported that a patient was admitted to the aicu (hospital name) on (b)(6) 2022 due to repeated coughing, expectoration and dyspnea for more than a month.On (b)(6), due to the continuous increase in respiratory parameters, the patient's condition did not improve.Vvecmo treatment was performed after multiple communication.On (b)(6), the family asked the hospital to be transferred the patient to (b)(6) hospital.When passing the bed at around 10:00 o´clock, the ecmo power cord was loose, the machine immediately went black and stopped running.The patient's blood oxygen saturation po2 dropped to 85%, immediately increase the breathing parameters, activate the ecmo hand crank and restarted ecmo after connecting to the power supply.After stabilizing the patient and all the preparations before the transfer, unplug the ecmo power cord, the ecmo can run normally, the battery voltage shows 21.6v, during the process of escorting the patient to the emergency 120 car (ambulance), the machine alarm prompts low voltage, and then the machine goes black and stops running again.The patient's po2 dropped to 80%, and emergency treatment was carried out immediately.After stabilization, the 120 car was connected to the power supply immediately.After arriving at the shenzhen people's hospital, the power was unplugged, the voltage displayed 23v, and the patient was successfully escorted to the icu of shenzhen people's hospital.After the incident was treated urgently, the patient's vital signs were stable.The rotaflow console with s/n (b)(6) was investigated by a getinge service technician and the technician was able to confirm the reported failure "low battery".The battery pack with fuse (article number (b)(6)) has been replaced.The battery is the first battery of the machine and has not been replaced since 2018.The battery has reached the end of its useful life.The root cause for the battery failure could be determined as the lifetime of the battery was passed and replacement overdue.The getinge field service technician advised the customer that the rotaflow console is a device produced in june 2018, and the battery has not been replaced since the installation.The customer was advised that the service manual state that the battery needs to be replaced every two years or if the battery cannot be fully charged within 8.5 hours, or if the battery cannot be fully charged and cannot keep the system running for 30 minutes.At present, the customer is aware of the battery problem.The cause of the occurrence is known by the customer.The most probable root cause for the reported "pump stop during transport" could be determined as a user error as the device was used out of the intended use of the device according to the instruction for use heart-lung support system rotaflow system| 4.4 | en | v15 chapter 2.1.4.Based on the investigation results the reported failures "low battery and pump stop during transport" could be confirmed but no product related malfunction.The review of the non-conformities was performed on 2022-03-02 and during the period of 2018-07-01 to 2022-03-02 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The rotaflow console in question was produced in 2018-07-01.In order to avoid reoccurrence of the reported failure "low battery", the sales and service unit (ssu) will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | v15.Chapter 3.3.4.Check battery capacity every 6 months, at the latest.The battery must be replaced by the authorized technical service every 2 years, at the latest.The battery must be replaced sooner if it cannot be fully charged within 8.5 hours or if the system cannot be operated with the fully charged battery.Chapter 5.6.1.Before starting the application, check the points listed in "check before every use".Before each use, ensure that the batteries are fully charged.If the battery capacity is low an acoustic signal sounds on the device.In order to avoid reoccurrence of the reported failure "pump stop during transport" the sales and service unit (ssu) will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | v15.Chapter 2.1.4.The rotaflow system is intended for use within clinical institutions.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 13648471
• MDR Text Key: 286425966
• Report Number: 8010762-2022-00069
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706291#ROTAFLOW PUMP MODULE
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1