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 Consequences Or Impact To Patient (2199)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information becomes available.

Event Description

It was reported that the touch panel was not responding during patient treatment.No indication of actual, potential for harm, or death.Complaint number: (b)(4).

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

It was reported that the touch panel was not responding during patient treatment.No indication of actual or potential for harm or death.According to the service order report (b)(4) (dated 2021-01-25/26) the getinge service technician replaced the ch user interface hardware update kit (701073922).After replacement the unit passed all tests and was cleared for clinical use.Thus the failure could be confirmed.The root causes for the reported failures to the cardiohelp touch panel is not responding is a known failure.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 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 cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.Note: the in the service order report (b)(4) mentioned defective venous bubble sensor will be investigated in the complaint#(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: 11064377
• MDR Text Key: 223393201
• Report Number: 8010762-2020-00456
• 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,foreign,health profe
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1