MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH ROTAFLOW CENTRIFUGAL PUMP SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 701046405 ROTAFLOW CHINESE ZH-PLUG

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that the error message "head err" occurred while in use.No indication of actual or potential harm to a patient.A head error causes a pump stop and therefore injury to the patient can not be excluded.Customer complaint number: (b)(4).

Manufacturer Narrative

The same failure was already investigated at emtec report no.(b)(4) on 2020-02-24 (complaint (b)(4); rma#(b)(4)): the defective drive was sent to the supplier (b)(4) for further root cause investigation: on 2020-02-24: (b)(4) report no.(b)(4): the reported head error is a result of wrong handling of the user see below causes.The reported failure could be reproduced and confirmed.Most possible root cause could be determined as: the head error is caused by the hot plug.When device is in operation and the power plug is plugged in or out.And this leads to a damage at the control board of the rotaflow.The head error follows by the sig error.This is when the ultrasonic crème is applied to the flow bubble sensor.Then the centrifugal pump is causing backflow and this leads to the head error.The head error is also caused by shaking the drive.This is when the motor (which is controlled by the optical tacho) is not blocked when adjusting to 0 then it could lead to error when slight shaking.The motor could then slightly rotate.The head error can be caused by connection issues between the console (rfc) and the drive (rfd).This is when the cable connection is disturbed by defective pins.Furthermore, the instructions for use of the rotaflow system, see rotaflow system user manuel, mcv-ga-10000703-de-11 contain detailed descriptions to prevent an ¿error head¿.The occurrence rate was calculated for the reported failure 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

Customer complaint number: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

Due to product return restriction from china this rotaflow drive was not returned at the time of the complaint was submitted.These restrictions were withdrawn by the chinese government at this time and therefore this rotaflow drive was returned for investigation at the supplier emtec.Therefore, this complaint is reopened to document the new investigation results and to determine a most probable root cause.The event occurred in china on (b)(6) 2019.It was reported that the error message ¿head error¿ occurred during use on the rotaflow drive.The error is still present after restarting the device.After a long period of testing it was determined that the rotaflow drive is faulty.The affected rotaflow drive with s/n (b)(6) was investigated on (b)(6) 2019 by a getinge field service technician and the technician was able to confirm the reported ¿head error¿.Due to import restrictions in china the repair of the rotaflow drive could not be performed by the supplier emtec at this time.A replacement rotaflow drive was sent to the customer.(b)(6) 2021: 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) 2021 the reported failure "head error" could not be reproduced.Thus, the drive was sent to the supplier emtec for further investigation.On (b)(6) 2021 the supplier emtec was unable to confirm the reported failure.After functional test at getinge service department on (b)(6) 2021 the device was sent back to the user.A device history record (dhr) review was performed on (b)(6) 2021.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on these investigation results the reported failure ¿head error¿ could not be confirmed, however, the failure mode "head error" can be linked to the following most possible root causes: - 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.In order to avoid reoccurrence of the reported failure, the sales and service unit (ssu) 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: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8743606
• MDR Text Key: 149792117
• Report Number: 8010762-2019-00198
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701046405 ROTAFLOW CHINESE ZH-PLUG
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1