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

Model Number RFD 20-973 ROTA FLOW DRIVE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/05/2022

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 closing assy of the rotaflow 2 used as a spare part for the rotaflow 1 is not properly fixed and came loose during patient treatment.The customer replaced the affected rotaflow with a backup device.No patient harm occurred.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the closing assy of the rotaflow 2 was used on a rotaflow and is not properly fixed and came loose during patient treatment.The customer was next to the patient and could fixate the part again without any harm occurring.A getinge service technician was on site on 2022-04-25 to repair the affected rotaflow (serial#(b)(6).The technician confirmed the reported failure and replaced the rf2 (rotaflow 2) drive closing cover kit (material#701076073) with the correct rfd (rotaflow drive) closing assy (material# 70101.1680).After the replacement the device is working as intended.At maquet cardiopulmonary it was found that the closing assy (material# 701073911) from the rf2 drive closing assy set (material# 701076073) does not fit perfectly on the rf drive unit (material# 701022161) of the rotaflow (material# 701051702) and therefore the closing assy does not close.The information regarding the rf2 (rotaflow 2) drive closing cover kit (material#701076073) will be handled in the non-conformance process.The complaint information (information regarding the drive closing cover kit) was transferred to the internal cp-sop-003 nonconformity process (nc no 3033131).Further investigations steps will be documented in the nc no 3033131.On 2022-07-18 a service bulletin has been send to the sales and service unit informing that the rf2 drive closing assy set (material# 701076073) is not equivalent to the rfd (rotaflow drive) closing assy (material# 70101.1680).This means, that the spare parts are only allowed to be installed into the designated drive as a closing assy.On 2022-09-01 the decision was made to start a fsca to replace the rf2 drive closing cover kit (material#701076073) that is already installed with the rfd closing assy (material# 70101.1680).A device history review (dhr) was performed on 2022-05-10 and the dhr does not show any abnormality or issue that is related or could have led to the customer complaint.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: 15273232
• MDR Text Key: 303144771
• Report Number: 8010762-2022-00331
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFD 20-973 ROTA FLOW DRIVE
• Device Catalogue Number: 701041378
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention