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 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information becomes available.A getinge service technician will investigate the cardiohelp in question.

Event Description

It was reported that the flow/bubble sensor quit reading.The event occured during treatment.The cardiohelp was changed.No harm to patient was reported.Complaint number: (b)(4).

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

It was reported that the flow/bubble sensor (flow probe) quit reading during treatment.No harm to any person has been reported.A getinge technician was sent for investigation on 2021-10-01.He could not confirm the failure and the device was put back in use.The log files also shows no malfunction of the device.Therefore, the reported failure "flow/bubble sensor (flow probe) quit reading" could not be confirmed.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-capatible sensor; environmental influences (atmospheric pressure, temperature, humidity, emi, overvoltage); bubble sensor cannot be plugged.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.

• 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: 12559861
• MDR Text Key: 274222657
• Report Number: 8010762-2021-00534
• 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: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1