MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; 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 Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A defective flow/bubble sensor was reported.The failure occurred during new installation of a loaner unit.No harm to any person has been reported.(b)(4).

Event Description

Complaintnumber: (b)(4).

Manufacturer Narrative

A defective flow/bubble sensor was reported during new installation of a loaner unit.Since this failure occurred during installation of the unit, the device has not been used by the customer to perform any medical intervention.Thus, the failure could not have happened during patient treatment.Therefore, based on this information, this complaint is not considered as a customer product complaint.The complaint information was transferred to the getinge nonconformity process.Therefore, this customer complaint investigation is concluded with this information.

• 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: 14641243
• MDR Text Key: 301356698
• Report Number: 8010762-2022-00207
• 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
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

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
• Device Catalogue Number: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1