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

Model Number ROTAFLOW CONSOLE

Device Problem Battery Problem (2885)

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

Event Date 12/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the error message ¿battery error¿ is displayed during patient transport and the device is shutting down.No harm to any person occurred.Complaint id:(b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow displayed the error message "battery error" during patient transport and the device is shutting down.A medical intervention was required.No harm to any person has occurred.A getinge service technician tested the affected rotaflow (serial# (b)(6)).The rotaflow was working as intended and the batteries have been replaced in (b)(6) 2021.It was found that the (uninterruptible power supply) of the hospital was causing the reported failure.The hospital has switched to not using ups any longer.The most probable root cause could be determined as the ups (uninterruptible power supply) which is used by the hospital.Based on these investigation results the reported failure could be confirmed.The product in question was produced in (b)(6) 2005.The review of the non-conformities has been performed on (b)(6) 2022 for the period of (b)(6) 2005 to (b)(6) 2021.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.Further mitigation are included in the instruction for use (ifu rotaflow| 4.3 | en | 14 ) as warnings in chapter 3.3.4 battery operation: 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.The actual run time during battery operation depends on the age and condition of the batteries, current consumption of the rotaflow console and other factors.The run time shown is only a reference value.The actual run time can be shorter or longer.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

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: 13072864
• MDR Text Key: 282701220
• Report Number: 8010762-2021-00669
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701028708
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention