MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH ROTAFLOW CENTRIFUGAL PUMP SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 701022161 - ROTAFLOW DRIVE UNIT, BLUE

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.Device not returned not eval.

Event Description

During power up a rotaflow drive showed a head error.Complaint# (b)(4).

Manufacturer Narrative

The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The defected rotaflow device was investigated by a maquet service technician with the service order report# (b)(4) on 2019-07-29: service observed the system and verified the head error.Service to acquire loaner rotaflow and will carry the rotaflow system back to the repair center in mahwah nj.The affected rotaflow drive was sent to germany under rma (b)(4) for investigation/repair by the manufacturer emtec.On 2019-09-05: the concerned drive was received by maquet.On 2019-09-09: the failure head error could be confirmed after testing in the service department.The device was investigated at emtec with the rma2019-1015 on the 2019-10-25.The failure could be confirmed.In addition liquid residues found on the electronics.The mc1 and mc2 circuit boards were damaged by liquid residues.Most probable root cause: mishandling the mast holder was leaking at the joint.A thread of the housing broke during disassembly.Possible root cause : aging.Housing renewed.All components damaged by the liquid levels have been replaced.New mast holder mounted: rfd has passed all tests.The rotaflow drive has been sent to the manufacturer emtec for repair.Thus the reported failure "head error" could be confirmed.Most possible root cause could be determined as: 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.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.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.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.

Event Description

During start up of the device a "head error" occurred.Complaint# (b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8882958
• MDR Text Key: 153992394
• Report Number: 8010762-2019-00240
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701022161 - ROTAFLOW DRIVE UNIT, BLUE
• Device Catalogue Number: 701022161
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1