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 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

A getinge service technician will investigate the affected cardiohelp.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was initially reported that there was an ecmo failure.Subsequently, a pump stop was reported.According to the technician, during treatment, the cardiohelp stopped, and the pump no longer turned.The hls set and the cardiohelp device were exchanged to a pls set and rotaflow.The hls set will be investigated in complaint # 959655.The failure occurred during treatment.No harm to any person has been reported.Complaint id # 956238.

Manufacturer Narrative

It was initially reported that there was an ecmo failure.Subsequently, a pump stop was reported.According to the technician, during treatment, the cardiohelp stopped, and the pump no longer turned.The hls set was exchanged top a pls set and was exchanged from the cardiohelp to a rotaflow device.No harm to any person has been reported.A getinge field service technician (fst) was sent for investigation on 2024-04-14.No parts were replaced.The failure could not be replicated.The fst tested the cardiohelp for two months without any failures.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 ¿pump disposable error ¿ stop¿ and ¿no disposable detected¿ could be confirmed in the log files.The log files were analyzed and according to the analysis, the failure was due to the disposable.According to the fst, the most probable root cause was that the hls circuit was incorrectly set up by the user.In the instruction for use (ifu) of the cardiohelp, it is stated that it is necessary to decrease the flow to zero before disconnecting and connecting the disposable to the device.In reference of the current ifu for disposables the following is stated in chapter ¿safety instructions for the oxygenator¿: incorrect installation of the hls module advanced can lead to device malfunction.This can endanger the patient.The following is stated: - use the device only together with the device cardiohelp-i.- install or remove the device only when the pump of the cardiohelp-i is at a standstill (0 rpm).- ensure that the device is fitted onto the device correctly and securely fixed, to eliminate the risk of magnetic decoupling between the drive and the centrifugal pump.The review of the non-conformities has been performed on 2024-02-14 for the period of 2016-08-23 to 2024-01-04.It does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The device was manufactured on 2016-08-23.Based on the results the reported failure "pump ¿ disposable error, due to hls circuit incorrectly assembled" could be confirmed, but could not be replicated by the fst.This complaint was found in the database of customer complaints for the cardiohelp device as a single event (timeframe from 2023-01-04 till 2024-01-04).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.Note: the hls set will be investigated in complaint # (b)(4).

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: 18533555
• MDR Text Key: 333095929
• Report Number: 8010762-2024-00026
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: 04/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1