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

Model Number ROTAFLOW SPANISH/SOUTH AM. US-PLUG ICU

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 01/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event occurred in (b)(6).It was reported that the rotoflow console does not charge the battery and turns off when the equipment is disconnected from the mains ac to be used in ambulances.New information received by the ssu.After charging for 24 hours, the user performed a functional test prior to transfer and the equipment failed, indicating error on its display.An engineer went to the site, charged the battery, disconnected the equipment from the electrical current, it was working for 90 minutes and when the equipment was reconnected to the electrical current, the equipment returned the same fault indicating "b temp error" in the display.There was no report about a patient being involved, as well as no information about a medical intervention.No indication of actual or potential for harm or death reported.(b)(4).

Manufacturer Narrative

It was reported that the rotaflow console does not charge the battery and turns off when the equipment is disconnected from the mains ac to be used in ambulances.Furthermore it was reported that after charging the battery for 24 hours, the user performed a functional test prior to transfer and the equipment failed, indicating error on its display.An engineer went to the site, charged the battery, disconnected the equipment from the electrical current, it was working for 90 minutes and when the equipment was reconnected to the electrical current, the equipment returned the same fault indicating "b temp error" in the display.No patient was involved in the event.A getinge field service technician has been sent for investigation.He could reproduce the failure and the power supply board was replaced.According to the service order (b)(4) dated on 2021-01-18 equipment diagnosis was performed.Equipment transformer check (set to 110v) battery to ac switchin test.Battery load test (equipment running on battery at 5000 revoluations per minute (rpm)) as stated by the ssu the battery was checked by an engineer an was working for 90 minutes.The battery has not been replaced.But the error "b temp" occurred.Accoding to the service order (b)(4) dated on 2021-01-27 the power supply board was replaced.Battery to ac switching test performed.Battery test run at 5000 rpm.The equipment is delivered working properly.The power supply board is replaced under warranty.It is recommended to connect the equipment to 110v to avoid damaging the new board.Based on the evaluated facts above, the reported failure "b temp error "could be confirmed.The failure mode "b temp" can be linked to the following most possible root causes according to our risk management file (dms# 2023689) 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 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: 11243088
• MDR Text Key: 229112662
• Report Number: 8010762-2021-00088
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW SPANISH/SOUTH AM. US-PLUG ICU
• Device Catalogue Number: 701054401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2021
• Patient Sequence Number: 1