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

Model Number ROTAFLOW CONSOLE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The rotaflow drive was investigated from a getinge service technician with the service order report# (b)(4).On the 2019-03-01: service troubleshot the system and determined the system was in need of repair at the factory in (b)(6).The following items were eliminated as the cause of the failure - flow measure board, control board and the power supply board.All were deemed operational.Service observation -lpm at 0 would fluctuate from 0.4 to 3.0 while in a zero state.System was removed from service and rma back to the (b)(6) facility.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).Customer stated the rotaflow was on a patient and displayed a "head error" while in use.Customer replaced the console with a backup console and continued patient use.No harm to the patient was reported.

Manufacturer Narrative

The rotaflow drive was investigated at emtec with the rma 2019-10114 on 2019-05-20: the failure could be confirmed.Therefore the ild 213(optocoupler)was defective and exchanged.Probable root cause: mishandling (hot plug.Rotaflow drive has passed all tests.The device was also investigated from field service of maquet with the customer order #rma id 37894 and the maquet- service order#:000010477511 on 2019-06-05.Problem description "alarms "error head" when rpm is set above 1500 additional work performed:investigation performed.Defective ild 213 replaced.Burn in, calibration and final check.System test performed according to service protocol.In the course of the investigation of nc-17-06-011 all complaints were analyzed individually to look for patterns and causes.After evaluation of the complaints, the following defects are the most common: hot plug, sig error followed by head error, error message due to shaking / error message due to sensitivity, connection problems and hardware-error.The increase in complaints with the error "head error" is due to a user / application error.The actions have been addressed in the past to prevent application errors.Furthermore, the instructions for use of the rotaflow system see rotaflow system user manual, mcv-ga-10000703-de-11, contain detailed descriptions to prevent an "error head".In addition, the instruction manual describes how the user has to react in case of an error message so that the application can be continued if possible.

Event Description

Internal reference: (b)(4).Autonumber: (b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8400712
• MDR Text Key: 141622034
• Report Number: 8010762-2019-00062
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention