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

Model Number ROTAFLOW

Device Problem Electrical Shorting (2926)

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

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a transfer the customer smelt a burnt smell.The rotaflow then stopped and could not be switched back on.The device has been exchanged with a backup device.Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow had a "burnt smell and the pump stopped.The failure occurred during patient treatment.The device has been exchanged with a backup device.No patient harm occurred.A getinge service technician was on site to repair the affected rotaflow on 2021-06-16.The technician confirmed the reported failure.In addition the technician found that the charging and battery indicator lights are not working anymore.The technician replaced the rfc (rotaflow console) power supply board (material #70101.1675).After the replacement the device is working as intended.The defect rfc power supply board (material #70101.1675) has been requested for further investigations at our life-cycle-engineering (lce, product specialists).The power supply board has been investigated in the lce on 2021-06-01 and following most probable root cause could be determined: during the visual inspection of the board it was found that the integrated circuit ic3 is burnt.The damage to the ic3 can be directly related to the described issues.The most probable root cause of the reported issue is an internal defect or short circuit in the ic3.The reason for that could be a wear out failure.The review of the non-conformities has been performed on 2021-06-21 for the period of 2016-01-18 to 2021-06-21.It 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 are unlikely.The product in question was produced in 2016-01-18.Based on these investigation results the reported failure could be confirmed.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: 11567206
• MDR Text Key: 242228930
• Report Number: 8010762-2021-00208
• 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: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• 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: 701028716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Date Manufacturer Received: 06/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention