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

Model Number MCP00706291#ROTAFLOW PUMP MODULE

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

The event occurred in china.It was reported that after the ecmo is turned on and running for a period of time, the monitored flow rate on the rotaflow console will gradually decreased.It was noticed during patient treatment.Preliminary judgment is that the lemo master connector failed.The device was exchange during treatment with another device without concequences for the patient.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.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in china.It was reported that after the ecmo was turned on and the rotaflow console was running for a period of time, the monitored flow rate on the device was gradually decreased.The device was exchange during treatment with another device.No harm to any person has been reported.The rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and during the investigation the technician was able to reproduce the reported failure and the lemo rfd master connector (article number 701034666) has been replaced.After the replacement a functional test was performed and the device is working as intended.The device is back in use.The event occurred in china.It was reported that after the ecmo was turned on and the rotaflow console was running for a period of time, the monitored flow rate on the device was gradually decreased.The device was exchange during treatment with another device.No harm to any person has been reported.The rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and during the investigation the technician was able to reproduce the reported failure and the lemo rfd master connector (article number 701034666) has been replaced.After the replacement a functional test was performed and the device is working as intended.The device is back in use.A similar complaint was investigated for the reported failure in getinge life-cycle-engineering (lce).The reported failure was caused most probably by a defective shielding in the coaxial cables which transmitted the ultrasonic signals to the flow measurement.Based on these investigation results the reported failure "flow rate incorrect (lemo master connector)" could be confirmed.The review of the non-conformities was performed on 2023-02-20 and during the period of 2020-09-14 to 2023-02-20 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 console in question was produced in 2020-09-14.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.Based on these investigation results the reported failure "flow rate incorrect (lemo master connector)" could be confirmed.The review of the non-conformities was performed on 2023-02-20 and during the period of 2020-09-14 to 2023-02-20 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 console in question was produced in 2020-09-14.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: 16402246
• MDR Text Key: 309967948
• Report Number: 8010762-2023-00090
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• 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: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1