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

Model Number ROTAFLOW CONSOLE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The field service technician (fst has been sent out for further investigation.According to the service order# (b)(4) dated on 2018-09-28 following was found: the customer told the fst that when they tried to raise rpm and they were unable to raise the rpm and then they smelled smoke or something hot.The fst opened the device and couldn't find any burnt components.The fst opened also the rotaflow drive and couldn't find any burnt components either.The fst performed full functional and safety tests.All tests passed.Furthermore, the fst performed preventive maintenance on separate service order that is due this month.Thus the failure could not be confirmed.In the course of the investigation of (b)(4) all complaints were analyzed individually to look for patterns and causes.The evaluated complaints were recorded in the years 2010-01-01 to 2017-05-31.After evaluation of the complaints, the following defects are the most common: - ¿hot plug¿ hot plug means to plug in and unplug the power while the console is still powered up.This can lead to voltage surges that can damage the rotaflow drive and the control board of the rotaflow.The instruction manual indicates that the rotaflow console must be switched off before connecting the rotaflow drive, as otherwise it may cause damage.Document id: (b)(4).- sig error followed by head error if the ultrasonic cream is reapplied to the flow and bubble sensor, it may result in a "head error".This is triggered by a return flow into the centrifugal pump.Even small amounts of reflux trigger a head error.(see also error message "wobbly") a detailed description of how to replace the contact cream can be found in rotaflow ifu, chapter 6.2 ultrasound - replacing contact cream, document id: (b)(4)11.- error message due to shaking / error message due to sensitivity if there is a shock on the rotaflow drive as a result of transport in the hospital (icu to the operating room) or a shock with the rotaflow drive, a head error can be triggered.The motor rotation of the drive is monitored at all times by an optical speedometer.If the knob is set to zero (0), the motor will not lock.This allows the motor to spin a little when the drive is shaken.- connection problems because the rotaflow drive is connected to the rotaflow console via a cable, head error may occur due to connection issues.This can e.G.Damage to the pins on the connector.- hardware - error: hardware error e.G.Of the control board conclusion of the investigation: the increase in complaints with the error "head error" is due to a user / application error.The actions have been addressed in the past to prevent application errors.Furthermore, the instructions for use of the rotaflow system, see rotaflow system user manual, (b)(4), contain detailed descriptions to prevent an "error head".In addition, the instruction manual describes how the user has to react in case of an error message so that the application can be continued if possible.Root cause / probable root cause since there are several causes of errors that result in an error head (error head) message, no final root cause could be determined.It is noticeable that the evaluated error is largely due to a user error.Corrections / action summary warning in the ifu regarding "hotplug" and label with the "hotplug" warning on the rfc have already been implemented in the past.Inform risk management the risk of an unintentional stop of the centrifugal pump caused by an "error head" error is evaluated in the risk analysis of the rotaflow console.The probability of occurrence of damage due to an unintentional stop of the centrifugal pump is valued at ptotal = 2.This corresponds to si-b-05 appendix 1 ver.9 is a probability of occurrence of 0.01 to 0.09 per rotaflow over their product lifetime.Due to the fact that all complaints reported to mcp did not suffer any damage, the actual frequency of occurrence is lower.This complaint will be closed based upon the within oxando generated documentation of the service carried out.If further documentation will get available and adds further relevant information this complaint will be re-opened, documentation updated and further necessary actions will be carried out if applicable.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

It was reported that the error message "head" was displayed during patient treatment.No known impact to the patient.(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 7965300
• MDR Text Key: 123941939
• Report Number: 8010762-2018-00276
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2018

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 CONSOLE
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1