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

Model Number CARDIOHELP

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information become available.A getinge field service technician will investigate the unit in question.

Event Description

An arterial flow/bubble sensor alarm during treatment was reported.The flow/bubble sensor alarm leads to a pump stop and the cardiohelp was changed.No indication of actual or potential for harm or death was reported.Complaint number: (b)(4).

Manufacturer Narrative

An arterial flow/bubble sensor alarm during treatment was reported.A getinge service technician was sent for investigation on 2021-12-13.The technician checked all possible root causes in regards to malfunctions of the digi flow board or the sensors.He could not confirm any malfunctions.The unit was tested and put back in use.Within the related support case the log files were analysed.The reported technical "arterial flow/bubble sensor alarm " could be confirmed, but no malfunction of the device.An exact root cause could not be identified.However, with reference to the current risk file the following most possible causes could be linked to the reported failure: wrong bubble sensor information; influence due to other ultrasonic devices (e.G.Flow sensor); connection of non-compatible sensor; environmental influences (atmospheric pressure, temperature, humidity, emi, overvoltage).Based on this results the reported failure "arterial flow/bubble sensor alarm" could be confirmed, but not a product related malfunction 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 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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12581802
• MDR Text Key: 274904833
• Report Number: 8010762-2021-00544
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1