MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH ROTAFLOW CENTRIFUGAL PUMP SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 701022161

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Device not returned.

Event Description

It was reported that the service technician discovered during preventive maintenance on a rotaflow the error message "head error".A patient was not involved.Complaint onetrack# (b)(4).

Event Description

Complaint onetrack# (b)(4).

Manufacturer Narrative

A getinge field service techinican was onside on 2019-05-07 to investigate the device in question.According to the service order report # (b)(4) the technician replaced the power supply and the connection cable.The unit was operated for 48 hours without issue and passed all functional and safety tests.This work was performed on 2019-05-13/14/16.Thus 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, (b)(4), chapter 8.1.2 detailed descriptions to prevent an ¿error head¿.The occurence 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.

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8665903
• MDR Text Key: 146938934
• Report Number: 8010762-2019-00156
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

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: 701022161
• Device Catalogue Number: 701022161
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention