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

Model Number 701043292 - ROTAFLOW ENGLISH/US US-PLUG

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Both console drive are displaying "error head" during a functional check.Onetrack complaint # (b)(4).

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

The review of the device history record (performed on 2019-07-31) did not show any abnormalities.According to service order (b)(4) the controller board had to be replaced.Repair performed on 2019-07-19 and 2019-08-05.The rotaflow drive was checked by the supplier and sent back to the sales and service unit.According to there information it was tested on 2019-10- 30.No service order was provided.Therefore it could not be confirmed that the drive had a malfunction.Regarding the console probable root cause could be already determined.1.The head error is caused by the hot plug.When device is in operation and the power plug is plugged in or out.And this leads to a damage at the control board of the rotaflow.2.The head error follows by the sig error.This is when the ultrasonic crème is applied to the flow bubble sensor.Then the centrifugal pump is causing backflow and this leads to the head error.3.The head error is also caused by shaking the drive.This is when the motor (which is controlled by the optical tacho) is not blocked when adjusting to 0 then it could lead to error when slight shaking.The motor could then slightly rotate.4.The head error can be caused by connection issues between the console (rfc) and the drive (rfd).This is when the cable connection is disturbed by defective pins.Furthermore, the instructions for use of the rotaflow system, see rotaflow system instruction for use |4-2 | en | chapter 8.1.2 contain detailed descriptions to prevent an ¿error head¿.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.

• 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
• MDR Report Key: 8873197
• MDR Text Key: 182547267
• Report Number: 8010762-2019-00233
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701043292 - ROTAFLOW ENGLISH/US US-PLUG
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1