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

Model Number ROTAFLOW ENGLISH/US US-PLUG ICU

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

The event occurred in (b)(6).It was reported that the flow was not measuring on the rotaflow console and on their measuring device during patient treatment.The unit tested and was running for 24 hours at 3.36 lpm (liter per minutes) at 2500 rpms (revolutions per minute) and the flow was measured.More information are 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.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the flow was not measuring on the rotaflow console and on their measuring device during patient treatment.No harm to any person has been reported.The affected rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and the reported failure could not be confirmed.During the investigation no issue could be determined.A functional test was performed, the device is working as intended and is back in use.Based on these investigation results the reported failure "not measuring flow" could not be confirmed.However the failure mode "not measuring flow" can be linked to the following most possible root causes according to our risk management file (dms# 2023689).Bubble/flow sensor failure, e.G.: dried contact gel.User forgot renewing contact gel.Sensor not detected although sensor is connected.Device used out of specification.The review of the non-conformities was performed on 2023-02-17 and during the period from 2015-09-15 to 2023-02-14 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 with s/n (b)(6) was produced 2015-09-15.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 | 15.6.2 reapplying ultrasonic contact cream.The ultrasonic contact cream can dry out and impair the functioning of the integrated flow/bubble sensor.In the "free" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message [sig!] appears.In the "stand al" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message [faultbub] appears.The error message [sig!] indicates an error in the integrated flow/bubble sensor, which may result in an incorrect flow display.The rotaflow centrifugal pump still continues to function.If the error occurs during lpm mode, the rotaflow system switches back to rpm mode automatically.9.1 cleaning: always clean after each use.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: 16441878
• MDR Text Key: 310248426
• Report Number: 8010762-2023-00102
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW ENGLISH/US US-PLUG ICU
• Device Catalogue Number: 701051712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1