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

Model Number HL 20

Device Problem Failure to Pump (1502)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.As soon as new information becomes available, a follow up medwatch will be submitted.

Event Description

It was reported that the hl20 device displayed the error message: "runaway" and the led was blinking during checking of the machine.No harm to any person was reported.Complaint id#(b)(4).

Event Description

Complaint id #(b)(4).

Manufacturer Narrative

It was reported that the hl20 pump displayed the error message: "runaway" and the led "l" was blinking during setup of the device.This is the battery charge indicator with "l" on the left side of the console under the main switch and it is blinking when there is a problem with the battery.A getinge field service technician (fst) was onsite for investigation of the pump in question.The fst adjusted the settings of the optical tacho voltage and replaced the batteries.After that the pump was working to factory specification.Device was manufactured in 2017-02-07 (mat#701043261).The review of the non-conformities during the period of 2017-02-07 to 2023-01-30 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.According to the service manual heart-lung machine hl 20 version 02 in chapter 6.11.6 adjustment of tpm optical tacho board the following is stated: the optical tacho must be adjusted after replacement or in case of speed differences between control system and safety system.The most probable root cause for the reported error message runaway could be determined as aging.Aging can change the properties of electronic components, which can cause it to have to be re-adjusted.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: HEART LUNG MACHINE
• 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: 16384915
• MDR Text Key: 309642941
• Report Number: 8010762-2023-00087
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL 20
• Device Catalogue Number: 701028580
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose