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

Model Number ROTAFLOW EN/NORTH AM US-PLUG

Device Problem Battery Problem (2885)

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

Event Date 09/28/2023

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 usa during patient treatment.It was reported that the rotaflow console unintentionally shut down upon switching to battery mode, stopping the pump.The rotaflow was then reconnected to ac power, upon which treatment continued as intended.The rotaflow was then exchanged for a backup device.The patient suffered no consequences from this event.No harm to any person has been reported.Complaint id (b)(4).

Manufacturer Narrative

The event occurred in the usa during patient treatment.It was reported that the rotaflow console (rfc) unintentionally powered down immediately upon being switched to battery mode.The rotaflow was reconnected to ac power and treatment continued as intended.The rotaflow was then exchanged for a backup device with no consequences for the patient.A getinge service technician investigated the rotaflow console serial# (b)(6).The technician confirmed the reported failure and replaced the "batterypack ni-cd 24v 132wh (rfc)" (material# 701017188) and the "rfc power supply pcba (printed circuit board assembly)" (material# 701011675).After the replacement the device is working as intended.A similar complaint has previously been investigated by life cycle engineering (lce), and the most probable root cause of the reported error is that the battery had an increased internal resistance.This could be caused by incorrect maintenance habits.But the actual cause in this case can not be determined.Based on these investigation results the reported failure "battery failure" could be confirmed.A review of non-conformities was performed on 2023-10-20, and during the time from 2014-09-22 to 2023-10-20 there are no non-conformities in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The rotaflow console in question was produced on 2014-09-22.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 17929130
• MDR Text Key: 325570201
• Report Number: 8010762-2023-00497
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW EN/NORTH AM US-PLUG
• Device Catalogue Number: 701046412
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention