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

Model Number HL 20

Device Problem Pumping Problem (3016)

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

Event Date 08/06/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hl20 roller pump module displayed the error message: "safety-s" during the self test.The getinge field service technician investigated the machine and confirmed the displayed error message.The technician reset the connections of pump control board and safety system board but still problem persist.The pump was cross checked with another pump control board and found as defective.A new pump control board is required for replacement.After the repair of the device has been performed, a follow up medwatch will be submitted.

Event Description

It was reported that the hl20 roller pump module displayed the error message: "safety-s" during the self test.The getinge field service technician investigated the machine and confirmed the displayed error message.The technician reset the connections of pump control board and safety system board but still problem persist.The pump was cross checked with another pump control board and found as defective.A new pump control board is required for replacement.

Manufacturer Narrative

The event occurred in india.No harm to any person was reported.The user reported that the hl20 pump displayed the error message: "safety-s¿ during self test.A getinge field service technician (fst) was onsite and investigated the unit in question.The fst confirmed the failure.The technician replaced the motor control board of the pump.After replacement the device worked to factory specification.The device is back in use.The defective control board was not available for further investigation.However this reported error message could be linked to the following root cause: an error occurs when transmitting the signals via the control board to the safety system board.This causes that the safety system board to receive no or incorrect data and therefore triggers the error message: "safety-s".With reference to the hl20 risk assessment (risk id: h1.1.1.2.7) this event can be contributed to: wrong pump speed because of: -communication error (e.G.Wrong ratio between master-slave pumps due to communication error) the device in question was manufactured in 2010-12-10.The review of the non-conformities during the period of 2010-12-10 to 2021-07-19 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.Thus the reported failure could be confirmed.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

Ref# (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: 15215886
• MDR Text Key: 302577588
• Report Number: 8010762-2022-00322
• 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,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• 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: 701027652
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2013
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose