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 Type  malfunction  

Event Description

It was reported that the hl20 twin pump displayed the error message: "head" during startup of the device.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the hl20 twin pump displayed the error message: "head" during startup of the device.No harm to any person has been reported.A getinge field service technician will be sent onsite for investigation of the device.As soon as new information becomes available a follow up medwatch will be submitted.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that the hl20 twin pump displayed the error message: "head" during startup of the device.No harm to any person has been reported.According to the getinge field service technician the customer replaced the defective optical tacho board locally by the hospital's technician.After replacement of the optical tacho board, full function was confirmed by the customer.The device is back in clinical use.The replaced optical tacho board was not available for further investigation.However the reported error message: "head" has been investigated in a previously complaint on (b)(6) 2019.The most probable root cause could be determined as a broken wiring of the optical tachoboard.Further the reported error message: "head" could be determined to the following most probable root cause according to the risk management file: (total) fail of device because of: defective tacho the device in question was manufactured on 2009-09-30.The review of the non-conformities during the period of 2009-09-30 to 2023-04-18 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.Based on the investigation results the reported failure "error message: "head"" could be confirmed.The customer will be informed about the investigation results from the getinge sales and service unit.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: 16867764
• MDR Text Key: 314545235
• Report Number: 8010762-2023-00204
• 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: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• 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: 701043262
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2009
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1