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

Model Number ROTAFLOW

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that after 2 hours of treatment the flow was not displayed anymore.The device has been exchanged.No patient harm occurred.Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was "no flow displayed" and occurred during patient treatment.The device was directly involved in the event and not able to meet its specifications.A field service technician was onsite to investigate the affected rotaflow console.According to the service order dated on 2020-11-25 a getinge service technician confirmed that the rotaflow was not displaying the flow.The 70101.1681 rfc (rotaflow console) flow measure board has been replaced and the rotaflow is working as intended again.The defect 70101.1681 rfc flow measure board has been requested for further investigation under the rma# (b)(4) for our life-cycle-engineering (lce).The flow measure board was received on 2021-01-19.The lce investigation was performed on 2021-01-25 under lce04459 with following result: the root cause is a faulty solder point between pin 4 of ic20 and the circuit board on the affected flow measure board.This resulted in a signal attenuation that jammed the generation of the ultrasonic signals.As a result the signal amplitude was only about half of the designed value and only slightly above the threshold for a reliable flow measuring.The product in question was produced in 2018-07-23.The review of the non-conformities during the period of 2018-07-23 to 2020-11-25 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 can be excluded.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
• MDR Report Key: 10918849
• MDR Text Key: 218687022
• Report Number: 8010762-2020-00413
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• 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: 70104.6405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention