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

Model Number ROTAFLOW

Device Problem Erratic or Intermittent Display (1182)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2021

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 the flow of the rotaflow is not displayed intermittently.The failure occurred during patient treatment and the device has been exchanged with a backup device.Complaint id:(b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow "flow display is working intermittently.If the error occurs during lpm mode, the rotaflow system switches back to rpm mode automatically.The rotaflow continues to function.A getinge service technician confirmed on 2021-07-13 that the customer did not use enough ultrasonic contact cream for the rotaflow drive flow/bubble sensor.Thus the flow on the lpm (liters per minute) display was shown intermittently.After the ultrasonic contact cream has been applied correctly the device is working as intended.The most probable root cause could be determined as wrong application of the ultrasonic contact cream on the rotaflow drive flow/bubble sensor.Based on these investigation results the reported failure could be confirmed, but no product related malfunction occurred.The product in question was produced in 2018-12-01.The review of the non-conformities has been performed on 2021-07-30 for the period of 2018-12-01 to 2021-07-10.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 | v14.6.2 reapplying ultrasonic contact cream: apply ultrasonic contact cream to both sides (left and right) around the outlet of the rotaflow centrifugal pump.Both sides must be completely covered with the 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.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.

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
• MDR Report Key: 12165660
• MDR Text Key: 261448928
• Report Number: 8010762-2021-00394
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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: 701046405
• Date Manufacturer Received: 07/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention