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

Model Number ROTAFLOW ENGLISH/US US-PLUG ICU

Device Problem Battery Problem (2885)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

The event occurred in the usa during patient treatment.It was reported that the rotaflow unintentionally shut down during patient transport.After connecting the rotaflow to ac power, the device could be powered on again and treatment continued as intended.The rotaflow was then exchanged for a backup unit.No harm to any person has been reported.Complaint id (b)(4).

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.

Manufacturer Narrative

The event occurred in the usa during patient transport.It was reported that the rotaflow console unintentionally shut down within one minute after switching to battery mode without displaying any error message.The pump stopped.The rotaflow was then reconnected to an ac power outlet, upon which it continued working as intended.The rotaflow was then exchanged for a backup device.There were no consequences to the patient from this event.A getinge service technician investigated the rotaflow console s/n (serial number) (b)(6).The technician was unable to reproduce the reported failure.After passing all functional tests the rotaflow was returned to customer for clinical use.No parts have been replaced.The reported failure could not be confirmed.However, the failure mode "battery failure" can be linked to the following most probable root causes according to the rotaflow risk management file: defect batteries.Power supply board failure.Software error.User forgot recharge.Defect of charger unit.A review of non-conformities was performed on 2023-09-01, and during the time from 2015-09-15 to 2023-09-01 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 2015-09-15.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | v15.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.

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: 17688864
• MDR Text Key: 322705410
• Report Number: 8010762-2023-00448
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW ENGLISH/US US-PLUG ICU
• Device Catalogue Number: 701051712
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention