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

Model Number MCP00703163#RFC 20-970 ROTAFLOW CONSOLE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from a customer from (b)(6) that during training with medical staff rotaflow console occasionally coming up with temp error.No more information provided.(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

Reported failure "temp error occasionally" during training of hospital staff.A getinge field service technician was onsite to investigate the device in question.According to the service order (b)(4) provided by the getinge field service technician dated on 2020-03-02 following work has been done: test system: no errors during testing.Check system usage since the replacement of the controller board.Rfc= 7 hours, rfd, s/n: (b)(6), = 14 hours.Replace the flow measuring board (701011681).Carry out an es test = passed.Electrical earth resistance = 0.178ohms (including isolation transformer circuit).Electrical isolation = ol (not including isolation transformer circuit).Electrical earth leakage = 22uamps (not including isolation transformer circuit).Run tests - no errors.Ask customer to run the system with a demonstration / test circuit until confident to use the system clinically.The instructions for use rotaflow| 4.2 | en | 13 was reviewed on 2020-04-01 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", page 76).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 2020-04-01 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 training of hospital staff 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.

• 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: 9773936
• MDR Text Key: 190541070
• Report Number: 8010762-2020-00089
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703163#RFC 20-970 ROTAFLOW CONSOLE
• Device Catalogue Number: 701028707
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/01/2020
• Patient Sequence Number: 1