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

Model Number ROTAFLOW DRIVE UNIT, BLUE

Device Problems Device Displays Incorrect Message (2591); No Flow (2991)

Patient Problem No Information (3190)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the initial complaint report it was reported that a customer from us needs quote for service.More information not provided.New information received on 2019-11-04 that the failure was "rotaflow console not giving flow".When the incident happened or if a patient was involved is unknown till now.(b)(4).

Manufacturer Narrative

The complaint was submitted with failure description ¿customer needs quote for service¿.Clarified with the ssu on 2019-10-31 the correct failure description.According to the supervisor technical support dated on 2019-11-01 the reported failure is ¿rotaflow not giving flow¿.Escalation via email on 2020-02-24.Asked if the rotaflow console with serial number (b)(6) is already repaired.Technician confirmed on 2020-02-28 that the unit is already repaired.Service order received.But the wrong service order was attached.Confirmed on 2020-03-02 that the wrong service order was provided.And it was told that the one which was requested is currently in germany for repair.2020-03-03 rma number requested by the technician.2020-03-03: rma# (b)(4) received.And it has been found out that not the rotaflow console (as provided in the initial complaint) is affected rotaflow drive with serial number (b)(6) was involved in the incident.The affected rotaflow drive was sent to the repair center in mahwah under ra (b)(4).The rotaflow drive was sent to germany for repair by the manufacturer emtec under rma#(b)(4) with the reported failure head error.2020-01-10: the concerned drive was received by maquet.2020-01-20: the failure head error could be confirmed after testing in the service department.Same failure was already investigated at em tec on 2017-02-27: the defective drive was sent to the supplier em tec for further root cause investigation: 2017-02-27: em tec 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: 1.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.2.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.3.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.4.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, chapter 8.1.2 contain detailed descriptions to prevent an ¿error head¿.It is unknown when the reported failure "head error" occurred but could be confirmed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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
• MDR Report Key: 9309551
• MDR Text Key: 195089884
• Report Number: 8010762-2019-00361
• 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: 03/04/2020

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 DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/04/2020
• Patient Sequence Number: 1