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

Model Number CARDIOHELP.I

Device Problem Pumping Stopped (1503)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the arterial bubble detection was activated which caused a pump stop after the priming was completed and the global override mode was turned off.The customer suspected a false detection of bubbles by the flow-/bubble sensor.No harm to any person has been reported.

Manufacturer Narrative

It was reported that the arterial bubble detection was activated which caused a pump stop after the priming was completed and the global override mode was turned off.The failure occurred during priming.A getinge field service technician (fst) was sent for investigation.The failure could not be replicated and no parts were replaced.The device was tested for a week with a simulated circuit and no failure occurred during that time.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.The log files of the reported cardiohelp device were reviewed and the detection of an arterial bubble 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 when a bubble was detected.The fst states further that the air bubble remained in the system due to inadequate priming, when the global override was turned off.A failure of the flow/bubble sensor could be excluded.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 2023-03-03.The device history record (dhr) of the cardiohelp (material: 701048012, serial: (b)(6) was reviewed on 2023-12-06.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the results the reported failure "pump stopped due to bubble detection" 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.

Event Description

Complaint id: (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: 18138246
• MDR Text Key: 328116718
• Report Number: 8010762-2023-00572
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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: 701048012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1