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

Model Number ROTAFLOW ENGLISH/US US-PLUG ICU

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

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 form the us that an unknown error message occurred on the rotaflow console during patient use and the pump stopped.The customer used the emergency drive during the replacement of the device.The device was running on a/c power, no battery power was activated.Batteries were fully charged.No indication of actual or potential for harm or death reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that an unknown error message occurred on the rotaflow console during patient use and the pump stopped.The customer used the emergency drive during the replacement of the device.The device was running on a/c power, no battery power was activated.The batteries were fully charged.No indication of actual or potential for harm or death reported has been reported.The affected rotaflow console (rfc) with s/n(b)(6) was investigated by getinge field service technician on 2021-01-06.The technician was found a non- functional mains socket with filter (without cabling).The mains socket with filter (without cabling) was replaced by the technician.The rotaflow console was tested and checked according to the service manual and passed all tests.The device is back in use by the customer.The affected part mains socket with filter (without cabling) with article number 701045731 was send back to the manufacturer for investigation.The affected part was investigated by the life-cycle-engineering (lce) and the reported failure "pump stop and unknown error message" could not be reproduced/confirmed.The mains socket with filter (without cabling) did not show any abnormal behavior.No indication of open or short circuits were identified.Moreover, the filter did not modify the input signals in the used frequency of 60hz.No soldering cold joints, broken or corroded parts were identified.A device history review (dhr) was performed on 2020-12-23 and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Based on these investigation results the reported failure "pump stop and unknown error message" could not be confirmed.However the failure mode "pump stop / unknown error message" can be linked to the following most possible root causes according to our risk management file (dms# 2023689).Pump stop intervention after technical error (e.G.Pump runaway, error head), wrong intervention limits, unintended rpm change by user, unintended switch off by user, defect of internal power supply (dc/dc).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: 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: 11064441
• MDR Text Key: 227112200
• Report Number: 8010762-2020-00457
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW ENGLISH/US US-PLUG ICU
• Device Catalogue Number: 701051712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Date Manufacturer Received: 08/05/2021
• Patient Sequence Number: 1
• Patient Age: 40 YR