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

Model Number CARDIOHELP-I

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A venous probe monitoring failure and a venous bubble sensor error was reported.No indication of actual or potential for harm or death.No pump stop was reported, but the venous bubble sensor alarm is a high priority alarm which normally leads to pump stop.Complaint number: (b)(4).

Manufacturer Narrative

A venous probe monitoring failure and a venous bubble sensor error was reported.A getinge service technician was sent for investigation on 2022-01-14.He could confirm the venous bubble sensor error in the log files.The defective venous bubble sensor was not sent with the cardiohelp for repair.The technician tested the cardiohelp with another venous bubble sensor and no malfunction could be detected.The customer was advised to check their own venous bubble sensor.As confirmed by getinge technician on 2022-02-01 no malfunction could be confirmed on the venous probe.The unit was tested and put back in use.Root cause reported failure: venous bubble sensor error: according to the current risk file the following root causes can lead to the reported failure: - influence due to other ultrasonic devices; - bubble sensor not plugged correctly; - connection of non-compatible sensor; - environmental influences (atmospheric pressure, temperature, humidity, overvoltage); - bubble sensor disturbed.Root cause reported failure: venous probe monitoring failure: according to the current risk file the following root causes can lead to the reported failure: - (partly) sensor failure; - wrong measurement values caused by sediments in the disposable; - light influences; - blood light spectrum differeces; - responce time is too long.Based on this investigation results, no 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: 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: 12622916
• MDR Text Key: 276116189
• Report Number: 8010762-2021-00554
• 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,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

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: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1