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 05/28/2022

Event Type  malfunction  

Event Description

It was reported that the hl20 double head pump reported the error message: "error head" during the operation.The pump head was replaced with another head and the pump was used without causing any harm to the patient.Reference number: (b)(4).

Manufacturer Narrative

It was reported that the hl20 double head pump reported the error message: "error head" during the operation.The pump head was replaced with another head and the pump was used without causing any harm to the patient.A getinge field service technician was onsite for investigation.As soon as new information becomes available, a follow up medwatch will be submitted.

Event Description

Reference number: (b)(4).

Manufacturer Narrative

User reports "head error" message on the hl 20 during priming.No harm to any person was reported.A getinge field service technician was onsite and investigated the unit in question.The hl 20 machine was checked throughly and no problem was detected during testing.The device is working properly.No parts were replaced.The device was put back into use.Thus the reported failure could not be confirmed.However the failure mode "head error" can be linked to the following most possible root causes according to the hl 20 risk management file (dms# (b)(4), version 11): -failure of pump control board -defective/ dirty tacho, relay or pump belt the device in question was manufactured on 2017-09-26.The review of the non-conformities during the period of 2017-09-26 to 2022-05-31 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.

• 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: 14632657
• MDR Text Key: 301632021
• Report Number: 8010762-2022-00204
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 70103.3557
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 07/17/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1