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

Model Number 701043292 - ROTAFLOW ENGLISH/US US-PLUG

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

The reported "b temp error" occurred during setup for patient use.A getinge field service technician was onsite to investigate the device in question.According to the service order (b)(4) dated on 2020-05-07 customer states rotaflow unit was being setup for patient use and plugged into a power outlet in the angio room.The customer said an audible clicking sound could be heard coming from the rotaflow as well as the battery light flickering.Customer moved the power cord to a boom in the room and had same issue.Customer also received an error message "b temp." unit was pulled from case and replaced with another rotaflow that had no issues when plugged into the same outlets.Upon arrival turned unit on with no alarms, attached test circuit, and ran unit on battery and ac with no issues @ 5,000 rpm, 7 lpm.Moved the ac power cord to different outlets in the room with no failures.Also plugged unit into a power strip with other equipment on it and the rotaflow had no errors.Was unable to duplicate the error after 2 hours of pumping.Recently replaced the expiring battery pack in (b)(6) 2020.In the interest of patient safety, replaced the battery pack.Unit passes all functional, safety, and electrical tests to factory specifications.Unit is cleared for clinical use and returned to customer.The instructions for use rotaflow| 4.2 | en | 13 was reviewed on 2020-05-14 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 2020-05-14 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 the reported failure "b temp error" occurred during setup for patient use and could not 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

It was reported from the us that customer states rotaflow unit was being setup for patient use and plugged into a power outlet in the angio room.The customer said an audible clicking sound could be heard coming from the rotaflow as well as the battery light flickering.Customer moved the power cord to a boom in the room and had same issue.Customer received an error message "b temp." unit was pulled from case and replaced with another rotaflow that had no issues when plugged into the same outlets.No patient was involved.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
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 10060348
• MDR Text Key: 203310994
• Report Number: 8010762-2020-00164
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701043292 - ROTAFLOW ENGLISH/US US-PLUG
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1