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 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

The field service technician (fst) was onsite for further investigation.According to the service report# 42843664 dated on 2018-11-13 following was found: the fst observed the system and replaced the control bd (material# 701034051, serial# (b)(4)) due to no audio sound from speaker and ran the system for 2 hours with no issue.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.The defective part has been requested for further investigation.A supplemental medwatch will be submitted after new information has been received.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).

Event Description

It was reported that the customer stated the rotaflow would display a "com" error message during use.The customer reset the system and continued therapy with no adverse affect to the patient.As a precaution the customer replaced the rotaflow console with a backup system after the case.No known patient harm.(b)(4).

Event Description

Internal reference: (b)(4).

Manufacturer Narrative

The defective part has been requested with rma# 36872 for further investigation in our life cycle engineering (lce).Part received on 2019-01-09.The returned control board 701034051 rf control board pcba kit was investigated in our life cycle engineering (lce) on 2020-02-19 under lce04089.A control board (rotaflowcontrol-cb) from a rotaflow console (rfc) was sent in for the investigation.The submitted rotaflowcontrol board has no visible serial number.The error could not be reproduced in several attempts.The signal transmission between the flowmeasurement board (fmb) and the rotaflowcontrol board and between the rotaflowconsole and the hl20 worked without problems in the tests which were carried out.The constellations that might have caused the error cannot be traced.It is therefore not possible to determine the cause of the error.Thus the failure could not be confirmed.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.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.

• 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: 8130100
• MDR Text Key: 129759093
• Report Number: 8010762-2018-00315
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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: MCP0.0702697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention