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

Model Number MCP00706291#ROTAFLOW PUMP MODULE

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

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

Event Date 03/10/2024

Event Type  malfunction  

Event Description

The event occurred in china.It was reported that the rotaflow drive makes abnormal noise and the closing assy was broken during use.No more information provided.More information requested but still pending.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 makes abnormal noise and the closing assy was broken before use by the customer.The customer wrapped the closing assy with tape and continued the treatment.No harm to any person has been reported.The affected rotaflow drive (rfd) with s/n (b)(6) was investigated by the getinge field service technician and the reported failures could be confirmed.During the investigation dust inside the rfd was detected which could lead to abnormal noise.The device was cleaned.The most probable root cause for the "abnormal noise" could be determined as dust inside the rotaflow drive.The broken closing assy will be replaced.According to instruction for use heart-lung supportsystem rotaflow system| 4.4 | en | 15.2.2.3 handling the rotaflow system take damaged devices out of service immediately and have them tested by the authorized service personnel.Changes or modifications made by the operator are not permitted.The customer was made ware by getinge ssu about this risk.The most probable root cause for the "broken closing assy" could be determined as excessive force by the customer.Based on the investigation results the reported failures "rfd loud noise and closing assy broken" could be confirmed.The review of the non-conformities was performed on 2024-03-12 and during the period of 2020-02-06 to 2024-03-11 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 rotaflow drive s/n (b)(6) was produced in 2020-02-06.In order to avoid reoccurrence of the reported failures "rfd loud noise and closing assy broken", 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 | 15.2.2.2 position of use and operation, and positioning: all connected parts, devices and modules must be firmly and correctly connected.Check mechanical stability.2.2.3 handling the rotaflow system: take damaged devices out of service immediately and have them tested by the authorized service personnel.Changes or modifications made by the operator are not permitted.9.1 cleaning always clean after each use.Clean the rotaflow system regularly 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.

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: 18892387
• MDR Text Key: 337553907
• Report Number: 8010762-2024-00135
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706291#ROTAFLOW PUMP MODULE
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1