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

Model Number ROTAFLOW DRIVE

Device Problem Failure to Read Input Signal (1581)

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

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during patient treatment the rotaflow displayed the message ¿sig¿.After reapplying the contact cream the failure still occurred.Therefore, the rotaflow drive has been exchanged.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow displays the error message "sig" during patient treatment.The device has been exchanged with a backup device.No harm to any person has been reported.After replacing the affected rotaflow drive (rfd) (serial#(b)(6)) the error message "sig" was no longer displayed.After the replacement the device is working as intended.The rfd was taken out of use and will be repaired.Based on these investigation results the reported failure could be confirmed.However, the failure mode "sig" can be linked to the following most possible root causes according to our risk management file (dms# (b)(4)).Bubble/flow sensor failure, e.G.: 1.Malfunction of bubble/flow sensor electronics; 2.Dried contact gel; 3.User forgot renewing contact gel; 4.Mechanical defects (impact); 5.Sensor not detected although sensor is connected.If relevant information regarding the product repair becomes available this complaint will be reopened.The product in question was produced in 2017-06-01.The review of the non-conformities has been performed on 2021-12-27 for the period of 2017-06-01 to 2021-11-05.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 user will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.3 | en | v14.The signal error (¿sig¿) indicates an error in the integrated flow/bubble sensor, which may result in an incorrect flow display.The rotaflow centrifugal pump continues to function.If the error occurs during lpm mode, the rotaflow system switches back to rpm mode automatically.The ultrasonic contact cream must be reapplied.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: 12859181
• MDR Text Key: 281130126
• Report Number: 8010762-2021-00622
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE
• Device Catalogue Number: 701022161
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention