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 01/09/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event occurred in usa during treatment.A "venous bubble defective" error message was reported.No harm to any person has been reported.Complaint number: (b)(4).The related hls will reported and investigated within complaint number: (b)(4).

Event Description

Complaint number: (b)(4).The related hls was reported and investigated within complaintnumber: (b)(4).

Manufacturer Narrative

A "venous bubble sensor defective" error message was reported.The failure occurred during treatment.A getinge service technician (fst) was sent for investigation and repair on 2022-01-13 and 2022-02-22.The venous bubble sensor was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.Another venous bubble sensor with the same failure was already investigated by the supplier: the most probable root cause was a mechanical wear on the plug and a damaged insulation on the cable.This caused a loose contact of the cable on the sensor.According to the instructions for use, chapters 2.2.5 (monitoring and sensors) and 5.4.4 (bubble monitoring: function test) the venous bubble sensor and the arterial flow/bubble sensor have to be tested before each use.The cardiohelp has a flow/bubble sensor for bubble detection.The optional venous bubble sensor is for additional bubble detection.Based on the results the reported failure "error message: venous bubble sensor defective" could be confirmed.The customer will be informed about the results by the getinge sales and service unit.The device history record (dhr) of the cardiohelp (material: 701048012, serial: (b)(6) ,elo#: 725896/v1) was reviewed on 2022-03-21.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.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: 13356498
• MDR Text Key: 284443442
• Report Number: 8010762-2022-00020
• 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: 05/05/2022

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: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female