MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP-I

Device Problems Pumping Stopped (1503); Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported that the cardiohelp stopped due to activated bubble intervention during treatment.The customer used the e-drive and the cardiohelp was exchanged.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

A follow up will submitted when additional information become available.

Event Description

Complaint id#: (b)(4).

Manufacturer Narrative

It was reported that the cardiohelp stopped due to an activated bubble intervention.The customer used the emergency drive and the cardiohelp was exchanged.The event occurred during treatment.A getinge field service technician (fst) was sent for investigation on 2023-10-19.No parts were replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp were reviewed and a pump stop as a result of activated bubble intervention could be confirmed on the date of event.According to the fst the root cause for the pump stop was due to an activated bubble intervention.Referring to the instruction for use of the affected cardiohelp device "chapter 3.1.5 "system modes" it is stated that with an activated intervention of the arterial flow/bubble sensor, a high-priority alarm and a pump stop will be generated.Further, with an activated intervention of the venous bubble sensor, a high-priority alarm and backflow prevention will be generated.If a lack of flow is detected by the arterial flow/bubble sensor, a pump stop is generated instead of a backflow prevention.Therefore, it can be conclude that the cardiohelp functioned in accordance with the factory specifications.Moreover, according to the instruction for use of the cardiohelp device (chapter 5.6.1 "check before every application") all functions/interventions of the cardiohelp must be checked before use.The device was manufactured on 2013-07-01.The review of the non-conformities has been performed on 2023-10-23 for the period of 2013-07-01 to 2023-08-22.It does not show any non-conformity in regard to the reported product and event.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.Based on the results the reported failure "cardiohelp stopped due to activated bubble intervention" could be confirmed, but is not a product related malfunction.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.

• 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: 17659258
• MDR Text Key: 322373026
• Report Number: 8010762-2023-00434
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• 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: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1