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

Model Number ROTAFLOW

Device Problem Increased Pump Speed (1501)

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

Event Date 06/01/2021

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 a rotaflow displayed the error message ¿runaway¿ during patient treatment.No patient harm occurred.Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow displays the error message "runaway".A getinge service technician was on site on (b)(6) 2021 to repair the affected rotaflow.The technician replaced the 70101.0990 potentiometer.After the replacement the device is working as intended.The 70101.0990 potentiometer has been requested for further investigation.As stated by the sales ad service unit on (b)(6) 2021 the part is no longer available for investigation.However the failure mode "runaway" can be linked to the following most possible root causes according to our risk management file (dms# (b)(4)).(un)intentional stop of the pump, e.G.: defective motor control electronics; pump stop intervention after technical error (e.G.Pump runaway, error head).Based on these investigation results the reported failure could be confirmed.A device history review (dhr) was performed on 2021-06-25 and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.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: 11998070
• MDR Text Key: 256172634
• Report Number: 8010762-2021-00351
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• 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: 70105.4401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention