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

Model Number ROTAFLOW GERMAN EU-PLUG

Device Problem No Display/Image (1183)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

It was reported that the ¿sig error¿ occurred on the rotaflow drive.The failure occurred during patient treatment.The device has been restarted several times to solve the reported failure.The device is still used on the patient.No harm to the patient has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the rotaflow displays the message"sig error".The device has been restarted several times to solve the problem.No harm to any person occurred.A getinge service technician confirmed on 2022-05-04 that the affected rotaflow (serial#(b)(4)) is working as intended.The failure cannot be reproduced.No parts have been replaced on the device.Based on these investigation results the reported failure could not be confirmed.However, the failure mode "sig error" can be linked to the following most possible root causes according to the rotaflow risk management file.Bubble/flow sensor failure, e.G.: dried contact gel.User forgot renewing contact gel.Device used out of specification.The product in question was produced in 2010-06-01.The review of the non-conformities has been performed on 2022-05-04 for the period of (b)(6) 2010 to (b)(6) 2022.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | 15.Chapter 6.2 reapplying ultrasonic contact cream the ultrasonic contact cream can dry out and impair the functioning of the integrated flow/bubble sensor.In the "free" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message [sig!] appears.In the "stand al" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message [faultbub] appears.The error message [sig!] indicates an error in the integrated flow/bubble sensor, which may result in an incorrect flow display.The rotaflow centrifugal pump still continues to function.If the error occurs during lpm mode, the rotaflow system switches back to rpm mode automatically.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.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.

• 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: 14350774
• MDR Text Key: 291369121
• Report Number: 8010762-2022-00159
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW GERMAN EU-PLUG
• Device Catalogue Number: 701043294
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention