MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number MCP00703157#RFC 20-970 ROTAFLOW CONSOLE

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The event occurred in japan.It was reported that the error message ¿"stop -- " occurred on the rotaflow flow console.Patient are not affected in any way because it was not occurred in clinical use.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

The event occurred in japan.It was reported that the error message ¿"stop -- " occurred on the rotaflow console during routine operation check by hospital staff and not during clinical use.No patient was involved.No harm to any person has been reported.The affected rotaflow console with s/n 1107 was investigated by a getinge field service technician and was unable to reproduce the reported failure.No parts has been replaced.A functional check was performed and the device is back in use.Based on the investigation results the reported failure "stop --" could not be confirmed.However, the failure mode "stop --" can be linked to the following most possible root causes according to the rotaflow risk management file.Pump stop intervention after technical error (e.G.Pump runaway, error head) software error.Wrong intervention limits.Unintended rpm change by user.Unintended switch off by user.Application of contrast agents.Defect of internal power supply (dc/dc).The review of the non-conformities was performed on 2023-02-20 and during the period of 2014-10-02 to 2023-02-20 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 rotaflow console was produced in 2017-09-16.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: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 16402760
• MDR Text Key: 309976426
• Report Number: 8010762-2023-00091
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991864
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703157#RFC 20-970 ROTAFLOW CONSOLE
• Device Catalogue Number: 701028716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose