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 09/07/2022

Event Type  malfunction  

Event Description

It was reported that the hl20 pump displayed the error message: "belt slip" during start up.No harm to any person was reported.Complaint id # (b)(4).

Manufacturer Narrative

It was reported that the hl20 pump displayed the error message: "belt slip" during start up.No harm to any person was reported.A getinge field service technician will be sent onsite for an investigation.As soon as new information becomes available a follow up medwatch will be submitted.

Manufacturer Narrative

It was reported that the hl20 pump displayed the error message: "belt slip" during start up.No harm to any person was reported.A getinge field service technician was onsite and investigated the unit in question.The foil on the optical tacho board was cleaned and the device was working without any problems.The system was checked according to factory¿s specification and all tests passed.No parts were replaced.The device was put back in use.Thus the reported failure could be confirmed.A dirty foil or a defective optical tacho board is a plausible cause for the error message "belt slip".Because the sensor no longer detects one or more lines on the film, it measures an apparently low speed at the pump head.Since this speed is then lower than the motor speed, the pump interprets this as a slipping belt and displays this message.The failure mode "belt slip" error message can also be linked to the following most possible root causes according to the hl 20 risk management file: -defective/ dirty tacho, relay or pump belt device was manufactured in 2011-06-10.The review of the non-conformities during the period of 2011-06-10 to 2022-09-16 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: 15474937
• MDR Text Key: 306263778
• Report Number: 8010762-2022-00382
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• 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: 701043262
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1