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 11/16/2021

Event Type  malfunction  

Event Description

It was reported that the error message "arterial bubble sensor defective" was displayed on the cardiohelp during treatment.The information received that the cardiohelp was changed.No harm was reported.Complaintnumber: (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that the cardiohelp alarmed "arterial bubble sensor defective¿ during treatment.A getinge service technician was sent for investigation on 2021-11-30 and 2021-12-02/03.He could confirm the failure.He replaced the sensor panel to restore function.The unit was tested an put back in use.A similar failure was already investigated within another complaint by getinge life-cycle-engineering.A malfunction could be confirmed.In order to determine a root cause the digiflow pcb was sent to the supplier emtec gmbh.The most probable root cause could be confirmed as a damage of the digiflow mini by electro static discharge (esd).The digiflow mini is part of the replaced sensor panel.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6), elo#: 1118549/v1) was reviewed on 2021-12-29.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on this results, the reported failure "arterial bubble sensor defective" 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 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: 12851495
• MDR Text Key: 281075624
• Report Number: 8010762-2021-00614
• 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: 12/31/2021

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
• Device Catalogue Number: 701072780
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1