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

Model Number CARDIOHELP

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A excessively high part reading while supporting a patient on cardiohelp was reported.They switched to a different pump and resolved the issue.Complaintnumber: (b)(4).

Manufacturer Narrative

A very high part reading during patient treatment was reported.The device was manufactured on 2016-12-01.The review of the non-conformities has been performed on 2021-03-24 for the period of 2016-12-01 to 2021-03-24.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded.On 2021-02-03 a getinge service technician was on site.He could not confirm the failure.The unit passed all tests and got back in use.Log files analysis of the cardiohelp system was performed on 2021-03-23 by getinge life-cycle engineering.The log files shows that the device had no malfunction.With reference to the current risk analysis v23 (dms# 2021972) the following most possible causes could be linked to the reported failure: - defibrillator system; - laser scalpel; - connection of non-capatible senor; - response time is too long ; - positive or negative pressure beyond specification (release of tubes); - too high / low atmospheric pressure.Based on the investigation results above, the reported failure "very high part reading " could not 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 cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint number: (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: 11214542
• MDR Text Key: 228218630
• Report Number: 8010762-2021-00023
• 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: foreign,health professional,u
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1