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

Model Number 701022161 - ROTAFLOW DRIVE UNIT, BLUE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported from the us that rotaflow drive has an temp error.No more details are provided.Complaint id: (b)(4).

Manufacturer Narrative

The reported "temp error" occurred during use but the device did not shut down, works as it should.A getinge field service technician was on site to investigate the device in question.According to the service order 43335063 dated on (b)(6)2020 temp err.Showing up in the flow display on the rotaflow console, checked the manual for the description of the error and it indicated the error is related to the flow sensor, ran the unit on a test circuit for approximately 1 1/2 hours and error came up, disassembled the rfd and checked for any air flow restrictions, all looks ok, put back together and retested, after 1 hour on the test circuit the (temp err) came up in the flow display on the rotaflow console again.This rotaflow drive will be shipped back to the repair depot.According to the service order 43348302 dated on (b)(6)2020 from the technician in the repair depot "temp error", ran the unit for for almost 24 hours at 2500 rpm and 4 lpm without any errors.Unable to verify the error.Tested per service manual.All tests passed.The instructions for use rotaflow| 4.2 | en | 13 was reviewed on (b)(6)2020 with the following outcome: in chapter 2.2 general safety instructions 2.2.2 position of use and operation, and positioning it is described as follows: - only operate the rotaflow system within the specific technical and ambient conditions (¿ "ambient conditions").Ambient temperatures outside of the specified conditions can disrupt the sensors' measurements.This may result in incorrect measurements, which may cause incorrect values be displayed and trigger alarms.There must be no risk of condensation.Condensation may occur when the device is taken from a cold environment into a warm room.- make sure that the ventilation openings are not obstructed and the rotaflow system is not covered.There is a risk that the rotaflow system will overheat.Ensure a minimum distance of 50 cm to other devices, objects, or the wall.The rotaflow risk analysis version v06 (dms# 2023689) chapter h1.1.1.10 was reviewed on (b)(6)2020 with the following outcome: the most possible causes for the reported failure "temp error" could be determined as: over-temperature condition in the device, e.G.: * increased heat generation due to short circuits * defect battery * heat accumulation * heat generation due to motor blockage * device used out of specification * charging of battery the reported failure "temp error" occurred during use and could not be confirmed.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
• MDR Report Key: 10038843
• MDR Text Key: 190493205
• Report Number: 8010762-2020-00154
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701022161 - ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2020
• Patient Sequence Number: 1