MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; DEPRESSOR, TONGUE, NON-SURGICAL

Model Number ROTAFLOW ENGLISH/US US-PLUG ICU

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/27/2023

Event Type  malfunction  

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

The event occurred in the us.It was reported that the error message ¿head error¿ occurred on the rotaflow console.More information requested but still pending.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that the error message ¿head error¿ occurred on the rotaflow console.No harm to any person has been reported.A getinge service technician in the national repair center checked the affected rotaflow console with s/n (b)(6) according to factory specifications.The technician was unable to reproduce the reported "head error".As part of the service the rf power plug us (article number 701073671) has been replaced.The device is working as intended and is back in use.Based on these investigation results the reported failure "head error" could not be confirmed.However, the following most possible root cause could be determined for the head error: 1.The head error follows the sig error.When the ultrasonic cream is applied (due to the sig error) to the flow bubble sensor and the disposable is moved close to the rota flow drive, the magnets in the centrifugal pump interfere with the sensors in the rota flow drive.This error can be overwritten by restarting the rota flow console.2.If the rpm / lpm is set to zero and the drive as well as the inserted centrifugal pump is shaken this causes magnetic uncoupling of the centrifugal pump and thus leads to the head error.This error can be overwritten by restarting the rota flow console.The review of the non-conformities was performed on 2023-04-05 and during the period of 2015-09-15 to 2023-04-05 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 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.Chapter 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.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: DEPRESSOR, TONGUE, NON-SURGICAL
• 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: 16680164
• MDR Text Key: 312687360
• Report Number: 8010762-2023-00162
• Device Sequence Number: 1
• Product Code: FMA
• Combination Product (y/n): N
• 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: 05/09/2023

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 ENGLISH/US US-PLUG ICU
• Device Catalogue Number: 701051712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 05/05/2023
• Supplement Dates FDA Received: 05/09/2023
• 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