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

Model Number ROTAFLOW CONSOLE

Device Problems Inappropriate or Unexpected Reset (2959); Output Problem (3005); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

The field service technician (fst) disassembled the unit, removed and replaced the control pcba (hl20 rpm) (material# 701007754, serial# (b)(4)) reassembled and tested per manufacture specifications.The unit passed all tests and calibrations and is now ready for clinical use.The defective control pcba (hl20 rpm) has been requested for return to germany to perform further investigation in our life cycle engineering (lce).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.(b)(4).

Event Description

It was reported that during preventive maintenance this unit failed with "safety-s" error and was stuck on a reboot cycle.No patient involvement.Internal reference: (b)(4).

Event Description

Internal reference: (b)(4).

Manufacturer Narrative

The investigation was performed in the life cycle engineering in rastatt and the report (b)(4) was received on 2020-04-09.A pump control board (material number 70105.3021 and spare part number 70100.7754), hereinafter called the dut, was received for investigation and testing.The pump control board exchanges signals with the rest of the boards in the system and processes the information to, for example, display the speed value or trigger errors.The dut was visually inspected; no damaged or missing components were detected.During functional testing a group of different errors were triggered during start up and the device conducted startup routines repeatedly.The reported reboot cycle was not of a power supply, but of a component failure nature ; no disturbances were observed in the voltage supply.The most probable root cause is a defective microcontroller ic1 on the pump control board.Thus the reported failure could be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary's trending program and additional investigations or corrections will be implemented in case of adverse trending.

• 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: 8041748
• MDR Text Key: 128255078
• Report Number: 8010762-2018-00297
• Device Sequence Number: 0
• Product Code: DTQ
• 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: 04/09/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW CONSOLE
• Device Catalogue Number: 701027652
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1