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

Model Number ROTAFLOW ENGLISH EU-PLUG ICU

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/04/2021

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).It was reported that the rotaflow console displayed the error message "x.? error¿ and the device stopped.Customer replaced the device with a medtronic device during use.No harm to the patient has been reported.The affected rotaflow console (rfc) with s/n (b)(4) was investigated by a getinge field service technician on (b)(6) 2021.The rfc was tested around 27 hours and the failure was not reproducible.No error messages or any alarms occurred on the device during testing.Functional check and safety tests were performed.The device was sent back to the user.Based on the investigation results the reported failure "x.? error¿ " could not be confirmed.However, the failure mode "x.? error¿ " can be linked to the following most possible root causes according to our risk management file dms# (b)(4).Pump stop intervention after technical error (e.G.Pump runaway, error head), sensor error (bubble, level, pressure (in hl20 mode), flow), wrong intervention limits, unintended rpm change by user, unintended switch off by user, application of contrast agents.The review of the non conformities was performed on (b)(6) 2021 and during the period of (b)(6) 2016 to (b)(6) 2021 does not show any nonconformity 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 in question was produced in (b)(6) 2016.The reported failure occurred during use and could not be confirmed.The device was directly involved in the event.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

The event occurred in (b)(6).It was reported that the rotaflow console displayed the error message "x.? error¿ and the device stopped.Customer replaced the device with a medtronic device during use.No harm to the patient has been reported.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: 12793004
• MDR Text Key: 280683469
• Report Number: 8010762-2021-00600
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW ENGLISH EU-PLUG ICU
• Device Catalogue Number: 701051696
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1