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

Model Number ROTAFLOW DRIVE UNIT, BLUE

Device Problem Mechanical Problem (1384)

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

The event occurred in china.It was reported that the rotaflow drive arm will not stay in position during surgery.The doctor wraps a bandage around the rotaflow drive arm.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 china.It was reported that the rotaflow drive arm will not stay in position during surgery.The doctor wraps a bandage around the rotaflow drive arm.The reported failure has no affect to the operation.No harm to any person has been reported.The affected rotaflow drive was investigated by a getinge service technician and the reported failure could be confirmed.The jh102238#hydraulik pin with o ring (material number 701023238) has been replaced.After replacement of the part the device is working as intended.Based on these investigation results the reported failure could be confirmed.The most probable root cause could be determined as normal wear and tear of the drive holder due to age of the device (produced in 2006).Further more the failure mode "drive arm will not stay in position" can be linked to the following most possible root causes according to the rotaflow risk management file.Malfunction or total fail due to mechanical influences, e.G.: 1.Falling of rotaflow system (broken holder, user routine violence).2.Loosening of fastening (wrong installation, aging).3.System falls to ground (transport in non-fixed manner, user routine violation).The review of the non-conformities was performed on 2022-11-16 and during the period of 2006 to 2022-11-16 does not show any non-conformity 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 affected rotaflow drive was produced in 2006 according to the material number mcp00967621.In order to avoid reoccurrence of the reported failure, the user will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | v15.Chapter 4.1.3: make sure that the screws are firmly tightened and that the rotaflow drive is securely fixed in place.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: 15733385
• MDR Text Key: 305145880
• Report Number: 8010762-2022-00435
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701010875
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1