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 12/14/2022

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

During service of the hl 20 machine the error message "head error" appeared.No harm to any person was reported.Complaint id (b)(4).

Manufacturer Narrative

During service of the hl 20 machine the error message "head error" appeared.No harm to any person was reported.A getinge field service technician (fst) was onsite and investigated the unit in question.After checking the hl 20 machine it was found that motor control board is defective.The defective motor control board was replaced with a new one.The system was checked according to factory¿s specification and all tests passed.The device was put back into use.Thus the reported failure could be confirmed.The defective motor control board was not available for further investigation.Therefore no technical investigation could be performed.However the failure mode "head error message" can be linked to the following most possible root causes according to the hl 20 risk management file: - failure of motor, motor controller or control circuitry - defective motor tacho (this is a part of the motor and is being evaluated by the motor control board for motor control) device was manufactured in 2010-01-28 (mat#701043261) the review of the non-conformities during the period of 2010-01-28 to 2022-12-14 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 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: 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: 16066463
• MDR Text Key: 308527336
• Report Number: 8010762-2022-00530
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 12/29/2022
• 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: 701043261
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1