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

Model Number ROTAFLOW CHINESE ZH-PLUG

Device Problem Battery Problem (2885)

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

Event Date 11/06/2023

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 china during patient treatment.It was reported that after being disconnected from ac power, the rotaflow would unintentionally shut down while being used in battery mode.The rotaflow was reconnected to ac power and treatment continued as intended, with no consequences to the patient.No harm to any person has been reported.Complaint id (b)(4).

Event Description

Complaint id (b)(4).

Manufacturer Narrative

The event occurred in china during patient treatment.It was reported that after being disconnected from ac power, the rotaflow would unintentionally shut down while being used in battery mode.The rotaflow was reconnected to ac power and treatment continued as intended, with no consequences to the patient.No harm to any person has been reported.A getinge service technician investigated the rotaflow console with serial number (b)(6).The technician confirmed the reported failure and determined that the "battery pack with fuse" (material# 70101.7188) will need to be replaced.A similar complaint has previously been investigated by life cycle engineering (lce), and the most probable root cause of the 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 cannot be determined.Based on these investigation results the reported failure "battery failure" could be confirmed.A device history record (dhr) review was performed on 2023-11-22.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 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.

• 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: 18110153
• MDR Text Key: 329202601
• Report Number: 8010762-2023-00562
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CHINESE ZH-PLUG
• Device Catalogue Number: 701046405
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention