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

Model Number ROTAFLOW

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 10/21/2021

Event Type  malfunction  

Event Description

It was reported that the flow of the rotaflow fluctuates between 0.35lpm (liters per minute) and 0.8lpm when set to 0.5lpm.The fluctuations occurred during patient treatment.The device has been exchanged with a backup device.No patient harm occurred.Complaint id:(b)(4).

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

Complaint id:(b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow "flow fluctuates".The failure occurred during patient treatment and the device has been exchanged with a backup device.No harm to any person has occurred.A getinge service technician checked the affected rotaflow (serial#(b)(6)).The technician was unable to reproduce the reported failure.The rotaflow is working within the specifications.The device has been returned for clinical use.Based on these investigation results the reported failure could not be confirmed.However the failure mode "flow fluctuates" 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.Dried contact gel; 2.User forgot renewing contact gel.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.According to instruction for use (instructions for use | 4.3 | en | 14; chapter 2.2.6) the flow measurements are less accurate with flows less than 2 lpm (liters per minute).An independent external flow measurement must be used in this flow range.The specifications in the ifu, chapter 13.6.1 describe a tolerance of up to + - 0.3lpm plus an off set drift of max.0.05lpm.The device is therefore within the specifications.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 product in question was produced in 2010-01-01.The review of the non-conformities has been performed on 20212-12-16 for the period of 2010-01-01 to 2021-10-21.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.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: 12766794
• MDR Text Key: 280451945
• Report Number: 8010762-2021-00586
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW
• Device Catalogue Number: 701043298
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention