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

Model Number CARDIOHELP-I

Device Problem Pumping Stopped (1503)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was taken out of service.

Event Description

Complaint number:(b)(4).It was reported that there was an issue getting the pressure readings from the disposable, but the pump stopped during patient treatment.No indication of actual or potential for harm or death.

Manufacturer Narrative

It was reported that there was an issue getting the pressure readings from the disposable, but the pump stopped during patient treatment.No indication of actual or potential for harm or death.The getinge service technician checked the device and could not find any malfunction.The sensor panel and the connection cable for internal sensors were replaced as a precautionary measure.After replacement, the device was able to work as per factory's specifications according to the results of the log file analysis, no failure was recorded on the date of event.Therefore, a pump stop can be excluded.According to the cardiohelp risk file the following root cause are probable: too high / low atmospheric pressure.Defective / disturbed pressure sensor (caused by electromagnitic interferences).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: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11243092
• MDR Text Key: 229354744
• Report Number: 8010762-2021-00090
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 70104.8012
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other