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

Model Number ROTAFLOW

Device Problem No Display/Image (1183)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

The initial failure description was that the customer "lost the flow reading" on the rotaflow.A getinge service technician was onsite on (b)(6) 2021 to investigate the affected rotaflow.The technician was unable to reproduce the reported failure.The rotaflow console (rfc) and rotaflow drive (rfd) both has little dust inside.The pins on the rfd as well as the connector on the rfc looked intact.The 70101.1681 rfc flow measure board has been replaced as a preventative measure.As part of the 2 year maintenance 70101.7188 battery pack with fuse has been replaced.The unit was calibrated and is working as intended.All tests have been passed.The review of the non-conformities has been performed on (b)(6) 2021 for the period of (b)(6) 2013 to (b)(6) 2021.It 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 can be excluded.The product in question was produced in (b)(6) 2013.Based on these investigation results the reported failure could not be confirmed.However the failure mode "lost flow reading" can be linked to the following most possible root causes according to our risk management file dms# (b)(4).Bubble/flow sensor failure, e.G.: malfunction of bubble/flow sensor electronics.Dried contact gel.User forgot renewing contact gel.Sensor not detected although sensor is connected.Device used out of specification.Malfunction of the flow measurement system: incorrect flow measurement.Device used out of specification.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.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.

Event Description

It was reported that the rotaflow stopped reading the flow value when a patient has been turned over.The device has been exchanged with a backup device.No patient harm occurred.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: 11782564
• MDR Text Key: 249294681
• Report Number: 8010762-2021-00290
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW
• Device Catalogue Number: 701051712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention