MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00703323

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Investigation will be performed during onside visit (investigation related to similar incidents/ complaints: (b)(4)).

Event Description

As stated by the customer: the twin pump did spin up to full rpm.This happened 3 times.On the first 2 occasions the pump span up to full rpm and the safety systems did stop the head.On the third occasion the perfusionist switched the pump off.No known consequences to the patient.Internal reference: (b)(4).

Event Description

Internal reference: (b)(4).

Manufacturer Narrative

T(b)(4).He issue has been already investigation by life cycle engineering (lce): complaints# 705007720 (mfr report# 8010762-2017-00069) and (b)(4).(mfr report# 8010762-2017-00405).According to investigation report by lce, dated on(b)(6)2018 , the investigation has been performed as follows: 1.Tested motor tacho (in the past, similar failures have been found with defective motor tacho) - test passed, no defective motor tacho has been found.2.Overpressure-test - test passed, the pump stopped as it should.3.Evaluation of the service interfaces - no abnormalities have been found.4.Tested "run-away"-monitoring - test passed, both the detection (display of "run-away" error message) and the conversion of an externally applied stop signal (pump stops), as well as the monitoring and control of the motor are working normally.5.Tested software: in 2009 there was already an accumulation of similar failures regarding tpm's used as a cardioplegia pump.At that time a data transfer issue (the csl slave receiving incorrect speed values from the cpl master) was identified.This software-issue has been solved with the new software-version 2.5.The affected tpm has already the updated software-version, therefore a software-issue can be excluded.Nevertheless, the software was analyzed to determine whether it is possible to increase pump speed as well as disable run-away and stop-signal monitoring due to a software malfunction.- no indication of a possible cause of software-malfunction.6.Tested the case of temporary, reversible defect (e.G.Short circuit) - test passed, pump stopped.7.Analysis of hardware changes to pump control board, motor control board and safety system board - none of these changes affect the function of the board.8.Tested the odu-connection of the tpm to the hl 20 base unit - the pump speed did not increase during the test.Since no indication of the cause of the failure could be found, neither regarding the tpm nor regarding the hl20 base unit, an onsite visit (at the derriford hospital) by representatives of the maquet departments r&d and technical service took place on 2018-07-04 and 2018-07-05.During onsite visit following points have been checked: - storage and transport - configuration of the hl20 - handling and cleaning by the hospital staff - power supply - possible interference caused by other devices (mri,ct,etc.) result of the onsite visit: no abnormalities or anything which indicates the cause of the failure (e.G.Misuse) were detected.Also during the onside visit four perfusion-protocols, which describes the failure in question as well as similar failures (complaints# (b)(6)2018 (mfr report# 8010762-2017-00405), (b)(6)2018 (mfr report# 8010762-2018-00061), 705009230 (mfr report# 8010762-2018-00194),(b)(4) (mfr report# 8010762-2018-00195) have been checked.In the lce-laboratory the operation conditions, described in the protocols, were reproduced.During the investigation in the laboratory no abnormalities have been found.Additional in february and october 2018, tests of electromagnetic compatibility were performed on two different hl 20 base units.At no point during the test any similar behavior or anything that might have led to it could be observed.Also at no time there was an autonomous increase of the speed of any connected pump.Finally the root cause could not be determined exactly.As this kind of failure happened striking often at one hospital (derriford hospital) a systemic external influence is most possible.The failure could not be reproduced, thus the failure could not be confirmed.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.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.Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4) rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption #(b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7553479
• MDR Text Key: 109766941
• Report Number: 8010762-2018-00195
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703323
• Device Catalogue Number: 701035075
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1