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 06/03/2022

Event Type  malfunction  

Event Description

A failing flow/bubble sensor was reported.No patient involvement and no harm to any person has been reported.(b)(4).

Manufacturer Narrative

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

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

A getinge service technician (fst) was sent for investigation and repair on (b)(6) 2022 the fst was able to confirm, that the flow/bubble sensor was causing false air alarms.The flow/bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.

Manufacturer Narrative

A failing flow/bubble sensor was reported.No patient involvement was reported.A getinge service technician (fst) was sent for investigation and repair on 2022-06-07.The fst was able to confirm, that the flow/bubble sensor was causing false air alarms.The flow/bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The flow/bubble sensor was investigated by getinge life-cycle-engineering on 2023-04-21 with the following result: the part and the log files were investigated and analyzed.The reported failure of the flow bubble sensor could neither be reproduced nor confirmed.According to the instruction for use chapter 5.3.1 connecting the combined flow/bubble sensor the bubble monitoring function test and flow off-set calibration has to be performed before every use.Thus a defective flow/bubble sensor should be detected prior to use, during priming.In addition as the cardiohelp includes pressure sensors and a venous probe it is able to measure and control the blood flow and parameters.If the measured values are above high limit or below low limit of the set limits the system generates a visual and acoustical alarm.The device was manufactured on 2020-12-02.The device history record (dhr) of the cardiohelp (material: 701072780, serial: (b)(6), elo#: (b)(4)) was reviewed on 2022-06-10.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the investigation results the reported "failing flow/bubble sensor" could be confirmed, but was not reproducible in the lce.The customer will be informed about the results by the getinge sales and service unit.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

Complaintnumber: (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: 14641244
• MDR Text Key: 301356737
• Report Number: 8010762-2022-00206
• 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,Followup
• Report Date: 04/28/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 07/06/2022; 04/24/2023
• Supplement Dates FDA Received: 08/02/2022; 04/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1