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

Model Number CARDIOHELP

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 08/15/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when new relevant information becomes available.

Event Description

Customer reported that while supporting a patient on cardiohelp the touchscreen was no longer responding to touch.The pump was then put into emergency mode until they could get another pump ready.Onetrack complaint #(b)(4).

Event Description

Complaintnumber: (b)(4).

Manufacturer Narrative

The cardiohelp was directly involved in the incident which occurred during treatment.It was reported that the touch panel was not responding.As stated by the technician in the communication grid of the complaint#(b)(4) the user interface hardware update kit (pn: 701073922 sn: (b)(6)) and new hmi board sn: (b)(6) was replaced.After replacement the unit passed all tests.(see also service order report 43487654).This work was performed on 2020-10-16/20/21.Based on this the reported failure "touch was not reponding"could be confirmed.The root causes for the reported failures to the cardiohelp touch panel is not responding is a known failure.The risk is mitigated in the cardiohelp risk analyses, chapter h1.1.3.18.The touch panel foil (material#70505.3579_rev.02) which was used formerly showed an increased rate of connection problems.As a solution for that a new touch panel was implemented as part of the cardiohelp user interface hardware update kit (material#70107.3922) in september, 2019.Regarding to the replacement of this part a service bulletin (issue 82 / 2019-09-25) was already provided.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: 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: 10448640
• MDR Text Key: 204211976
• Report Number: 8010762-2020-00271
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other