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 09/27/2022

Event Type  malfunction  

Event Description

The event occurred in india.It was reported that the hl20 pump displayed the error message: "direct" when starting up.The getinge field service technician found a defective optical tacho board which needs to be replaced.The part was ordered.No patient was involved.Ref#: (b)(4).

Manufacturer Narrative

The event occurred in india.No patient was involved.It was reported that the hl20 pump displayed the error message: "direct" when starting up.The getinge field service technician found a defective optical tacho board which needs to be replaced.The part has been ordered.As soon as new relevant information becomes available, a follow up medwatch will be submitted.

Manufacturer Narrative

The event occurred in india.It was reported that the hl20 pump displayed the error message: "direct" when starting up.No patient was involved.A getinge field service technician was onsite for an investigation.After replacement of the optical tacho board no error message was detected and the device works to factory specification.The defective optical tacho board was not available for further investigation at the manufacturer site.However the failure mode "direct" error message can be linked to the following most possible root causes according to the hl 20 risk management file: -total fail of device because of defective tacho, relay or pump belt.The device in question was manufactured on 2018-05-15.The review of the non-conformities during the period of 2018-05-15 to 2022-10-14 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

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: 15579287
• MDR Text Key: 306639305
• Report Number: 8010762-2022-00401
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose