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

Model Number 701043292 - ROTAFLOW ENGLISH/US US-PLUG

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The affected rotaflow console was in the service depot for the preventive maintenance.According to the service report (b)(4) from the getinge technician from 2019-12-11 following work has been done: 2 year service, pm, calibration check, full functional test and safety check as per the service manual.All tests passed.The rotaflow console also had parts that were bad also causing a head error.Those parts (701011675 rf power supply pcba and 701034051 rf control board pcba kit) were replaced and tested as per service manual.All tests passed.This mentioned head error was already handled in complaint (b)(4).According to the service order (b)(4) broken part on the flow measurement board.Replaced part (701011681 rf flow measure pcba) and tested per service manual.All tests passed.The reported failure "del error" occurred during service and could be confirmed.The device was directly involved in the incident.The reported failure "del error" was already investigated by our lce in complaint (b)(4): the defective flow measuring board was requested on 2018-03-22 with rma#34295 for investigation in lce(life cycle engineering) at (b)(6).The investigation of the board was carried out on (b)(6) 2018 with the report #(b)(4) and came to following result: on the board a solder joint on potentiometer pot3 is broken.Since the potentiometer is located at the very front of the edge of the board, it is possible that it was damaged during maintenance, especially since the error occurred only during maintenance.Pot3 controls the gain of the measurement amplifier in front of the adc.Since the connection on the wiper of the potentiometer has stopped, regulation is no longer possible.Thus, the ultrasonic measuring system does not work anymore.This explains the offending error.The error "txre" or "txrx" has not occurred.Conclusion: a solder joint of potentiometer pot3 is broken.This disturbs the amplification of the ultrasonic signals and disrupts the flow measurement.This explains the failure reported.Most probable root cause is a mechanical influence during maintenance.Thus the failure could be confirmed.The service technician has replaced the defective flow measuring board.The reported failure is not due to a malfunction of the device.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

It was reported from the us that the technician in the service depot was replacing boards for the head error and got a new error in the flow window on the rotaflow console."del.Err" was displayed in the flow window.No patient was involved.(b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 9466862
• MDR Text Key: 193631779
• Report Number: 8010762-2019-00392
• 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: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701043292 - ROTAFLOW ENGLISH/US US-PLUG
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1