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

Model Number MCP00706035#ROTAFLOW ENGLISH/US US-PLUG

Device Problems Overheating of Device (1437); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2022

Event Type  malfunction  

Event Description

The event occurred in the us.It was reported that the complained rotaflow console in this complaint is the replaced rotaflow console which was mentioned in complaint (b)(4).The same issue occurred as in complaint (b)(4) when the customer unplugged the console the battery went from 26v to battery failure in less than a minute.The customer was able to use the emergency drive and provide support while they turned the rotaflow off and back on and plugged back into the wall outlet and resumed support safely.No harm to the patient per the customer.This unit in question is also a rental unit.More information requested but still pending.No harm to any person has been reported.Complaint id: (b)(4).This complaint is related with complaint id: 727613.

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

The event occurred in the us.This complaint is connected to the rotaflow english/us us-plug icu complaint id#(b)(4) (mfg#8010762-2022-00474).It was reported that the error "b temp" occurred during patient use.The customer was able to use the emergency drive and provide support while they turned the rotaflow off and back on and plugged back into the wall outlet and resumed support safely.No harm to the patient has been reported.The unit in question is a rental unit.No harm to any person has been reported.The affected rotaflow console with s/n (b)(6)was investigated by a getinge service technician in the repair center.The technician was unable to confirm the reported failure.As part of the service the rf power plug us (article number (b)(6)) and one hl20_rubber foot 24x12 rpm/tpm (article number (b)(6)) has been replaced.The device is working as intended and is back in clinical use.Based on the investigation results the reported failure "b temp" error could not be confirmed.However, the failure mode "b temp error" can be linked to the following most possible root causes according to our risk management file: heat accumulation.Device used out of specification.Charging of battery.The review of the non-conformities was performed on 2022-12-01and during the period of 2008-10-01 to 2022-12-01 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The rotaflow console in question was produced in 2008-10-01.In order to avoid reoccurrence of the reported failure, the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | 15.Chapter 2.2 general safety instructions - only operate the rotaflow system within the specific technical and ambient conditions.- 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.- 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 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).This complaint is connected to the rotaflow english/us us-plug icu complaint id#(b)(4)(mfg#8010762-2022-00474).

• 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): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 15892107
• MDR Text Key: 306686361
• Report Number: 8010762-2022-00475
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706035#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: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1