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

Model Number ROTAFLOW

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver (2338)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the rotary knob could not be operated when connected to the patient.No flow could be established.The device has been exchanged with a cardio help.No patient harm occurred.Complaint id:(b)(4).

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.The affected rotaflow drive has been requested for further investigation.

Event Description

New information regarding the failure description has been received on (b)(6) 2021.The rotaflow displays the error message "head error" when reaching 1500 revolutions per minute.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The reported failure "head error" occurred during patient treatment.The device has been exchanged with a backup device.No patient harm occurred.A getinge service technician was send onsite for repair on (b)(6) 2021.The technician replaced the 70103.4051 rfc control board kit.The rotaflow consoles is working as intended again.The technician found that the rotaflow drive also needed to be repaired.The affected drive with s/n (b)(6) was sent back to manufacturer for repair.It was received on (b)(6) 2021 and during investigation by the service department on (b)(6) 2021 the reported failure "head error" could not be reproduced.Thus the drive was sent to the supplier emtec on (b)(6) 2021 for further investigations.On (b)(6) 2021 emtec was unable to reproduce the reported "head error" on the rotaflow drive.The following most possible root cause could be determined for the head error: the head error is caused by the hot plug.When the device is in operation and the power plug is plugged in or out the head error occurs and the rota flow drive and/or the control board is damaged.As a result the rota flow drive and/or the control board has to be replaced.The product (rotaflow console with serialnumber (b)(6)) in question was produced in (b)(6) 2010.The review of the non-conformities has been performed on (b)(6) 2021 for the period of (b)(6) 2010 to (b)(6) 2021.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 can be excluded.The product (rotaflow drive with serialnumber ((b)(6)) in question was produced in (b)(6) 2010.The review of the non-conformities has been performed on (b)(6) 2021 for the period of (b)(6) 2010 to (b)(6) 2021.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 can be excluded.Based on these investigation results the reported failure "head error" could be confirmed on the roaflow console.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| 4.2 | en | v13.Chapter 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.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.

• 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: 11300587
• MDR Text Key: 230954724
• Report Number: 8010762-2021-00102
• 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,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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: 701043294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention