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

Model Number MCP00706035#ROTAFLOW ENGLISH/US US-PLUG

Device Problem Battery Problem (2885)

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in the us.It was reported that a patient was put on a rotaflow console on (b)(6) 2021.At 7:05 pm on (b)(6) 2021 a low battery alarm occurred on the console.The customer tried plugging the unit into different outlets and was unable to reestablish power.The operator claimed the unit was plugged in and running on ac power when the first and only low battery alarm occurred.The operator proceeded to hand crank for 45 minutes while they were waiting for another console and more clinical support.There was no harm to the patient who is awake and responding to comments.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that a patient was put on a rotaflow console (rfc) on (b)(4) 2021.At 7:05 pm on (b)(4) 2021 a low battery alarm occurred on the console.The customer tried plugging the unit into different outlets and was unable to reestablish power.The operator claimed the unit was plugged in and running on ac power when the first and only low battery alarm occurred.The operator proceeded to hand crank for 45 minutes while they were waiting for another console and more clinical support.There was no harm to the patient who is awake and responding to comments.The affected rotaflow console with (b)(6) was investigated by a getinge field service technician on (b)(4) 2021.The technician was unable to confirm the reported failure.The unit passed the battery run time test.Functional check and safety tests were performed.The device was sent back to the user.Based on the investigation results the reported failure "low battery alarm" could not be confirmed.However, the failure mode "low battery alarm" can be linked to the following most possible root causes according to our risk management file ((b)(4)) user forgot recharge a device history record (dhr) review was performed on 2021-09-29.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.In order to avoid reoccurrence of the reported failure, the sales and service unit (ssu) will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.2 | en | v13.Chapter 3.3.4 check battery capacity every 6 months, at the latest.The battery must be replaced by the authorized technical service every 2 years, at the latest.The battery must be replaced sooner if it cannot be fully charged within 8.5 hours or if the system cannot be operated with the fully charged battery.Chapter 5.6.1 before starting the application, check the points listed in "check before every use".Before each use, ensure that the batteries are fully charged.If the battery capacity is low an acoustic signal sounds on the device.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: 12552913
• MDR Text Key: 273983662
• Report Number: 8010762-2021-00529
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706035#ROTAFLOW ENGLISH/US US-PLUG
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/04/2021
• Patient Sequence Number: 1