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 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the hl20 pump displayed the error message: "belt slip".No patient was involved.A getinge field service technician will be sent onsite for investigation of the pump.As soon as new relevant information becomes available, a follow up medwatch will be submitted.

Event Description

It was reported that the hl20 single pump displayed the error message: "belt slip".No patient involvement reported.Ref# (b)(4).

Manufacturer Narrative

It was reported that the hl20 single pump displayed the error message: "belt slip".No patient involvement reported.A getinge field service technician (fst) was onsite and investigated the unit in question.The hl 20 machine was checked and it was found that the optical tacho board is defective and needs to be replaced.After replacement the device works to factory specification.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 2013-02-04.The review of the non-conformities during the period of 2013-02-04 to 2022-06-17 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

(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: 14828792
• MDR Text Key: 301947063
• Report Number: 8010762-2022-00247
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL 20
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1