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

Model Number MCP00706291#ROTAFLOW PUMP MODULE

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up will be submitted when additional information becomes available.

Event Description

The event occurred in china.It was reported that the error message ¿head error¿ occurred on the rotaflow console and the pump stopped during use.The speed was by 3200 rpm (revolutions per minute) and flow rate was 2,5 liter.The device can´t be used normally after the device was turned on again.The hospital immediately replaced the machine with another device.No harm to any person has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in china.It was reported that the error message ¿head error¿ occurred on the rotaflow console and the pump stopped during use.The speed was by 3200 rpm (revolutions per minute) and flow rate was 2,5 liter.The device can´t be used normally after the device was turned on again.The hospital immediately replaced the machine with another device without consequences for the patient.No harm to any person has been reported.The rotaflow console (rfc) with s/n number (b)(6) and the rotaflow drive (rfd) with s/n (b)(6) was investigated by a getinge field service technician and the technician was able to confirm the reported "head error" on the rotaflow drive.The rotaflow drive (rfd) with s/n (b)(6) was sent back to manufacturer for repair.During the investigation by the getinge service department on 2023-06-14 the reported "head error" could not be reproduced.Thus, the drive was sent to the supplier emtec for repair.On 2023-07-05 the supplier emtec was unable to reproduce the reported failure "head error".Preventively, the electrical parts has been replaced by the supplier.After functional test at the getinge service department on 2023-07-14 the device was sent back to the user.The reported failure "head error" could not be confirmed, however the following root causes could be determined for the head error: the head error follows the sig error.When the ultrasonic cream is applied (due to the sig error) to the flow bubble sensor and the disposable is moved close to the rota flow drive, the magnets in the centrifugal pump interfere with the sensors in the rota flow drive.This error can be overwritten by restarting the rota flow console.If the rpm / lpm is set to zero and the drive as well as the inserted centrifugal pump is shaken this causes magnetic uncoupling of the centrifugal pump and thus leads to the head error.This error can be overwritten by restarting the rota flow console.Rota flow console: a device history record (dhr) review was performed on 2023-02-06.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Rotaflow drive: a device history record (dhr) review was performed on 2023-08-02.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | 15.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16302677
• MDR Text Key: 308827639
• Report Number: 8010762-2023-00071
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706291#ROTAFLOW PUMP MODULE
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1