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

Model Number MCP0.0702879

Device Problem Defective Component (2292)

Patient Problem Death (1802)

Event Date 09/25/2019

Event Type  Death  

Manufacturer Narrative

A getinge field service technician was on site to perform initial investigation on the device in question.According to the service report the getinge field service technician replaced the bubble detector and tested the unit.The hl20 unit passed all tests and is returned for clinical service.A supplemental medwatch will be submitted after new information has been received.

Event Description

In usa it was stated that the hl20 bubble detector would not reset during a case.The operator had to leave it on override while the patient was on.The patient expired.No further details available yet.Complaint# (b)(4).

Manufacturer Narrative

A rma for retur was started in order to return the involved bubble detector and atm module for further investigation and root cause analysis.Furthermore, the field service technician provided following information via e-mail dated on (b)(6) 2019: the patient expired, but the expiration of the patient had nothing to do with the bubble sensor issue.The patient was being treated on ecmo and was in bad condition when they were put on ecmo.From what the field service technician gathered from the ecmo perfusionist, the patient was near expiration when they went on ecmo.A supplemental medwatch will be submitted after new information has been received.

Event Description

Complaint# (b)(4).

Manufacturer Narrative

It was reported that the bubble detector wouldn¿t reset.For this reported adverse event a medical review was requested on 2019-09-30.The medical review was received on 2019-12-17 with the following conclusion: the bubble sensor of the hl20 could not be reset, potentially because of the missing cover clip at the rotaflow drive.It is unknown why the cover clip was missing.The user solved the problem according to the instruction for use.As no air entry is described, the medical device malfunction had nothing to do with the patient expiration.Lce (life cycle engineering ) performed the investigation according to report (b)(4) on 2020-06-18 as follows: a bubble/level detection module (apm, sn (b)(6) , part no.70105.3011) of type 20-414 (only bubble detection) and a bubble sensor (sn (b)(6) , part no.70105.4546) of a hl20 were returned for investigation.During visual inpection of the apm it is noticeable that the connection socket for the bubble sensor is not firmly seated in the front panel of the housing and the stop potentiometer is bent.On the electronic boards inside, no other abnormalities could be detected.The bubble sensor was also visual inspected and it was detected that the isolation on the cable of the bubble sensor was damaged.Since optical abnormalities do not explain the malfunction at first, the apm and the bubble sensor must be installed in a test device.The hl20 detects a bubble, but no bubble alarm was provoked with the test tube.This is not fully reproducible and cannot be clearly identified due to missing information.The most probable root causes for the reported failure could be determined as: a loose contact or cable break at the socket for the bubble sensor or at the plug/cable of the bubble sensor.The faulty isolation on the bubble sensor cable may also have had an influence on the malfunction.Also possible, but not to be narrowed down further, would be a sporadic defect of a microprocessor (ic2 or ic4).Thus the reported failure could be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

(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
• MDR Report Key: 9179008
• MDR Text Key: 162008706
• Report Number: 8010762-2019-00319
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP0.0702879
• Device Catalogue Number: MCP0.0702879
• Device Lot Number: MCP0.0702879
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death