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

Model Number ROTAFLOW ENGLISH/US US-PLUG

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2020

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 the us that b temp error message displayed with audible clicking sound when rotaflow console plugged in.No person harm reported, unit was replaced with another rotaflow.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The reported failure "b temp error" occurred during use.Unit was sent to national repair center (ncr) on rma # 6932002173 to be evaluated.(b)(6) will be working on this unit once it is received at the nrc.According to the service order 43354273 dated on (b)(6)2020 rotaflow that has an intermittent problem with the charging circuit.The unit gives error message ¿b temp¿ replaced the battery that was just installed as it had a date code of 2018-01, which means it sat around for over 2 years without a charge.The one i installed has a (b)(6)2020 date code.Fully charged it then discharged it per the service manual.Then recharged it to full again.All tests passed.I'm going to let it run over the weekend on my hl20 test fixture to be certain of no failures.Unit ran without any failures.The instructions for use rotaflow| 4.2 | en | 13 was reviewed on (b)(6)2020 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 2020-06-02 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 use 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.

• 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: 10093845
• MDR Text Key: 193677306
• Report Number: 8010762-2020-00177
• 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: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• 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
• Device Catalogue Number: 701043292
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/02/2020
• Patient Sequence Number: 1