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

Model Number ROTAFLOW CHINESE ZH-PLUG

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 02/04/2023

Event Type  malfunction  

Event Description

It was reported that a rotaflow displayed the error message ¿head error¿ when the speed exceeded 3000 rpm and the pump stopped during use.The failure occurred during patient treatment.The hospital immediately replaced the machine with another device.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

The event occurred in china.It was reported that a rotaflow console (rfc) displayed the error message ¿head error¿ when the speed exceeded 3000 rpm (revolutions per minute) and the pump stopped during use.The hospital immediately replaced the machine with another device without consequences for the patient.A getinge service technician was on site to investigate the affected rotaflow console with s/n (b)(6).The technician was able to confirm the reported "head error".The rfc control board pcba (printed circuit board assembly) kit (article number (b)(4)) has been replaced on the rfc.The rotaflow console is working as intended.Furthermore, it was detected that the rotaflow drive (rfd) with s/n (b)(6) was also detected as defective.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 (b)(6) 2023 the reported "head error" could 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the supplier emtec was unable to reproduce the reported failure "head error".Preventively, the electrical parts has been replaced by the supplier.After functional test at the getinge service department on 2023-07-14 the device was sent back to the user.The following most possible root cause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.Based on these investigation results the reported "head error" could be confirmed on the rotaflow console but not on the rotaflow drive.Rotaflow console: the review of the non-conformities was performed on 2023-06-16 and during the period of 2015-11-08 to 2023-06-16 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 rotaflow console in question was produced in 2015-11-08.Rotaflow drive: the review of the non-conformities was performed on 2023-08-02 and during the period of 2018-09-13 to 2023-08-02 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 rotaflow console in question was produced in 2018-09-13.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.

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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16320441
• MDR Text Key: 309018901
• Report Number: 8010762-2023-00076
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CHINESE ZH-PLUG
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1