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

Model Number CARDIOHELP-I

Device Problem Communication or Transmission Problem (2896)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the unit alarmed "ven bubble sensor defective" during treatment.A getinge service technician (fst) was sent for investigation and repair on (b)(6) 2021.According to the service order report #43700777 the service technician was not able to reproduce the issue.The customer stated that the defective sensor had been swapped and was scrapped.The log files were reviewed by getinge technical service and the error "ven bubble sensor defective" could not be confirmed.Rather the message "venous bubble detected" was logged.Based on the investigation results the reported failure "venous bubble sensor defective" could not be confirmed.As defined in the cardiohelp risk assessment following probable root causes for venous bubble detection were determined: influence due to other ultrasonic devices.Bubble sensor not plugged correctly.Environmental influences.Bubble sensor disturbed.The occurrence rate was calculated for the reported failure 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

Reporting decision re-evaluated: the customer reported that the unit alarmed "ven bubble sensor defective", it was in use on a patient and there was no harm reported.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: 12346688
• MDR Text Key: 267430655
• Report Number: 8010762-2021-00464
• 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
• Report Date: 08/19/2021

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-I
• Device Catalogue Number: 701072780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1