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

Model Number ROTAFLOW CONSOLE

Device Problem Increased Pump Speed (1501)

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

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 rotaflow cover for d sub plug has been replaced.In addition the rotaflow displays the error message ¿runaway.¿ the failure were discovered during maintenance of the device.No patient has been involved when the failure occurred.The reported ¿runaway error¿ can cause an unintentional pump stop.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in germany.It was reported that the d-sub cover of the rotaflow was defective.In addition the rotaflow displays the error message ¿run-away¿.The failures were discovered during the maintenance of the device.No patient has been involved when the failure occurred.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 failures "d-sub cover broke and the error message "run-away" could be confirmed.The rfc (rotaflow console) flow measure board (article number 70101.1681) and the rf d-sub cover (article number 701073.413) has been replaced.A functional check of the device was performed and is back in use.The failure mode "d-sub cover defective" 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.: falling of rotaflow system (broken holder, user routine violence).Collision with environment during patient transport.Loosening of fastening (wrong installation, aging).The reported failure "run-away error" was already investigated by our life-cycle-engineering (lce) with the following results: a rotaflow flow measuring board was under investigation following a complaint regarding the error message ¿run-away¿ in the lpm-mode during the preventive maintenance.The reported failure ¿run-away¿ could be reproduced during the investigation when the lpm-mode is activated at a speed below 1500rpm (revolutions per minute) if the zero flow calibration has not been performed as required by the ifu (instruction for use).The probable root cause could be determined as a defective signal processor mo1 which can lead to this message.Based on the investigation results the reported failures "d-sub cover broke and the error message "run-away" could be confirmed.The review of the non-conformities has been performed on 2022-11-29 for the period of 2008-07-01 to 2022-11-24.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.The product in question was produced in 2008-07-01.In order to avoid re-occurrence of the reported failure error "run-away", 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 | 15.5.5 calibration: to achieve the specified flow accuracy, calibrate the flow sensor, check its functionality before each application and define the current blood temperature range.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: 15894100
• MDR Text Key: 306686565
• Report Number: 8010762-2022-00479
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701043294
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1