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

Model Number ROTAFLOW

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Device evaluated by mfr: device not returned/not eval.

Event Description

It has been reported that rotaflow had an head error during start up of device.No patient involved.Complaint#: (b)(4).

Event Description

Complaint#: (b)(4).

Manufacturer Narrative

Failure description: head error" was displayed once when rpm`s are above 1500 on the rfc.The rotaflow console was investigated with the maquet -service order number (b)(4) by a getinge service technician on the 2019-08-20 and 2019-08-29: in house rotaflow repair service ticket details.Repair, pm, calibration check, full functional test and safety check as per service manual.All tests passed.The "head error" was verified by the service technician.Therefore the 70103.4051 control board was replaced.Investigation of the defective control board forwarded to our lce on 2017-02-10.With the investigation report lce e03240 and the rma# 3512 of the complaint (b)(4) with the defective control board after showing the failure "head error" on the rotaflow display: the defective control board was investigated by our life cycle engineering (lce).Due to the failure description and the defect on the drive the first assumption was a "hotplug" (disconnect the drive while the console is on).According to the report from our lce the ic3 has a short cut between pin 13 (input schmitt-trigger)and pin 14 (vcc).This blocks one of the speed signals by the drive and puts the console in fail mode (head error) at a chosen rpm of above 1000 rpm.Probable root cause is a defective rfd.The rotaflow drive was also repaired at the factory.Reference trackwise complaint# (b)(4) head error.Factory states rfd by replacement of defective ild.Reference so# (b)(4) for all rfd complaint information and all of its test measurements.In the course of the investigation of (b)(4) 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 (b)(4), 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.Since there are several causes of errors that result in an error head (error head) message, no final root cause could be determined.It is noticeable that the evaluated error is largely due to a user error.Warning in the ifu regarding "hotplug" and label with the "hotplug" warning on the rfc have already been implemented in the past.

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• MDR Report Key: 8627507
• MDR Text Key: 145631119
• Report Number: 8010762-2019-00128
• 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: 08/30/2019

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
• Device Catalogue Number: 701043292
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1