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

Model Number CARDIOHELP-I

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

It was reported that the patient leakage test failed.The failure occurred during maintenance.Complaint id # (b)(4).

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

Complaint id # (b)(4).

Manufacturer Narrative

It was reported that the patient leakage test failed.According to the technician the leakage current was higher than the specification.The failure occurred during maintenance.The device caused the complaint and was not able to work as per factory¿s specifications.A getinge field service technician (fst) was performing maintenance on 2023-11-10.The sensor panel was replaced.The fst performed safety, calibration, and functionality checks to factory specifications.All function tests are passed.A similar failure of the patient leakage test was investigated by getinge life-cycle-engineering (lce) on 2023-08-11.The exceeding of the value limit affects only the sensor panel da0, in which a higher capacitor value was installed.As an action the sensor panel was revised under a capa.Referring to the instruction for use of the cardiohelp device (chapter 4.5 "connecting external devices (optional)") it is stated to check the total leakage currents if the cardiohelp device will be used together with other medical devices.Additionally, as stated in the service manual (cardiohelp system, service requirements) only authorized service technicians are allowed to carry out service-related work.Thus the issue can only occur during service of an authorized service technician.The product in question was produced on 2010-12-01.The review of the non-conformities (nc) has been performed on 2023-08-11.An nc regarding the reported failure was found.In order to address this failure a capa was initiated on 2022-08-03 (ongoing).The following corrective action is implemented in the fsca#881841 for the failure concerning the patient leakage current test: contact the customer to arrange the performance of the patient leakage current test according to iec 62353 and subsequent repair, if necessary or the return of the cardiohelp to a getinge representative based on the results the reported failure " patient leakage test failed " could be confirmed.The customer will be informed about the results by the getinge sales and service unit.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: 18117593
• MDR Text Key: 327874078
• Report Number: 8010762-2023-00563
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/17/2023

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: 11/03/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1