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

Model Number RFC 20-970 / ROTAFLOW CON

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

The event occurred in italy.It was reported that the error message ¿head error¿ occurred by turning on the device.Additionally, the closing assy has been found as damaged.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the error message ¿head error¿ occurred by turning on the device.Additionally, the closing assy has been found as damaged.The reported ¿head error¿ could lead to a pump stop during use therefore a report is required.No harm to any person has been reported.A getinge service technician investigated the affected rotaflow console with s/n (b)(6) and was able to confirm the reported "head error".The rfc (rotaflow console) power supply pcba (printed circuit board assembly) (article number 701011675) has been replaced.Furthermore, the rf drive closing cover kit (article number 701011680) has also been replaced.After the replacement the device is working as intended.An investigation of a rotaflow system that exhibited a similar issue "head error" was performed by the getinge life cycle engineering (lce) and the most probable root cause could be determined as a defect fuse f4 on the power supply board of the rotaflow console.The cause of the defect fuse f4 is probably outside of the rotaflow console.The reported failure "closing assy broken" was already investigated by the getinge life cycle engineering (lce ) and the most probable root causes could be determined as: - too excessive force - weakening due to manufacturing errors (air inclusions) - weakening due to aging.Uv light (sun) or contact with chemicals.Based on the investigation results the reported failure "head error / closing assy broken" could be confirmed.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 | 15.Chapter 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.The customer will be informed about the results by the getinge sales and service unit.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: 18473204
• MDR Text Key: 333092067
• Report Number: 8010762-2024-00015
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFC 20-970 / ROTAFLOW CON
• Device Catalogue Number: MCP0.0702697
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1