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

Model Number ROTAFLOW ENGLISH EU-PLUG ICU

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 12/13/2020

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 israel that the b temp error occurred on the rotaflow console.The battery was exchanged but the error occurred again.When the reported failure occurred was not provided.No indication of actual or potential for harm or death reported.Complaint id: (b)(4).

Manufacturer Narrative

The device in question was investigated by a getinge field service technician.The technician checked the device and replaced according to the part removed grid the rf power supply board (701011675) was replaced.The device was tested after the replacement.The instructions for use rotaflow| 4.2 | en | 13 was reviewed on 2021-02-03 with the following outcome: in chapter 2.2 general safety instructions 2.2.2 position of use and operation, and positioning it is described as follows: - only operate the rotaflow system within the specific technical and ambient conditions (¿ "ambient conditions", page 76).Ambient temperatures outside of the specified conditions can disrupt the sensors' measurements.This may result in incorrect measurements, which may cause incorrect values be displayed and trigger alarms.There must be no risk of condensation.Condensation may occur when the device is taken from a cold environment into a warm room.- make sure that the ventilation openings are not obstructed and the rotaflow system is not covered.There is a risk that the rotaflow system will overheat.Ensure a minimum distance of 50 cm to other devices, objects, or the wall.The rotaflow risk analysis version v06 (dms# 2023689) chapter h1.1.1.10 was reviewed on 2021-02-03 with the following outcome: the most possible causes for the reported failure "b temp error" could be determined as: over-temperature condition in the device, e.G.: * increased heat generation due to short circuits * defect battery * heat accumulation * heat generation due to motor blockage * device used out of specification * charging of battery a device history review (dhr) was performed and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.The reported failure "b temp error" 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: 11051677
• MDR Text Key: 225385053
• Report Number: 8010762-2020-00444
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW ENGLISH EU-PLUG ICU
• Device Catalogue Number: 701051696
• Date Manufacturer Received: 02/01/2021
• Patient Sequence Number: 1