MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 701028716 - ROTAFLOW JAPANESE US-PLUG ICU

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported from a customer from (b)(6) that while using rotaflow for patients on (b)(6).An error message appeared while moving to the icu and rotation stopped.The power was turned on again, but the error could not be cleared, so the patient was transferred to the icu after replacing it with rotaflow emergency drive.The treatment could be continued by switching to another instrument at the icu.No health damage to patients was reported.The exact error message was requested but customer does not remember whether the surgeon was in a hurry.Immediate replacement of the equipment did not cause any health damage to the patient.Complaint id: (b)(4).

Manufacturer Narrative

The reported failure "unknown error message" occurred during use and the customer replaced the rotaflow drive with a new one.As stated by the getinge field service technician dated on 2020-04-15 in the communication grid the exact error message could not found out.Customer does not remember whether the surgeon was in a hurry.By checking the device it was confirmed that the power supply boad had dropped out.The problem was solved by improving it.The power supply board has not been replaced.The problem was solved by reattaching the board that was detached.The rotaflow risk analysis version v06 (dms# 2023689) chapter h1.1.1.3 was reviewed on 2020-04-16 with the following outcome: the most possible causes for the reported failure "unknown error message" (exact error message coud not found out) could be determined as: (un)intentional stop of the pump, e.G.: * defective motor control electronics; * pump stop intervention after technical error (e.G.Pump runaway, error head); * sensor error (bubble, level, pressure(in hl20 mode), flow); * software error; * wrong intervention limits; * unintended rpm change by user; * unintended switch off by user; * freeze of microcontroller sab80c517; * defect of micro controller pici 14000; * defect of transformer*; defect of internal power supply (dc/dc).The reported failure "unknown error message" occurred during patient treatment and 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.

Event Description

Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9837630
• MDR Text Key: 195116868
• Report Number: 8010762-2020-00107
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701028716 - ROTAFLOW JAPANESE US-PLUG ICU
• Device Catalogue Number: 701028716
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2020
• Patient Sequence Number: 1