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

Model Number CARDIOHELP-I

Device Problem Failure to Sense (1559)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Service of the affected cardiohelp unit and further product data is requested but not yet received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that during scheduled training with perfusion, they noticed erroneous bubble alarm information from venous bubble sensor during a patient use.After cleaning the sensor and also unplugging and plugging the problem disappeared.There was no patient impact at all during the incident.During a training on 2021-09-21, the getinge technician was able to duplicate the erroneous venous bubble alarm and was able to confirm that one of the getinge demo sensors resolved the problem immediately.Complaint id #(b)(4).

Manufacturer Narrative

A venous bubble sensor alarm was reported during patient use.This information was given during scheduled training with perfusion in the hospital.Customer cleaned, unplugged, plugged and the problem disappeared.No harm to the patient was reported.During another training (on (b)(6) 2021), the customer was able to duplicate the failure and was able to confirm that one of the getinge demo sensors resolved the problem.The customer has received a new venous bubble sensor and replaced it by himself.In (b)(6) 2021 a getinge service technician performed a preventive maintenance.The technician performed safety, calibration, and functionality checks to factory specifications.The logfiles provided by the service technician shows that the intervention for a pump stop was not set by the customer and therefore bubble alarm did not lead to a pump stop.The defective venous bubble sensor (serial# (b)(6)) is not available, but however this failure can be linked to the risk assessment file of the cardiohelp: influence due to other ultrasonic devices.Bubble sensor not plugged correctly.Connection of non-compatible sensor.Software failure.Environmental influences (atmospheric pressure, temperature, humidity, overvoltage).Bubble sensor disturbed.Based on the investigation results the reported failure "venous bubble sensor alarm " 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 id # (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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12525187
• MDR Text Key: 273169742
• Report Number: 8010762-2021-00519
• 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: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 701048012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1