Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number MCP00706291#ROTAFLOW PUMP MODULE
Device Problems Pumping Stopped (1503); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The event occurred in china.It was reported that the rotaflow console suddenly shut down during treatment.A battery problem was suspected.The device was replaced with another one without consequences for the patient.No harm to any person has been reported.Complaint id: (b)(4).
 
Manufacturer Narrative
The event occurred in china.It was reported that the rotaflow console suddenly shut down during treatment.A battery problem was suspected.The device was replaced with another one without consequences for the patient.No harm to any person has been reported.As confirmed by getinge ssu (sales and service unit) dated on (b)(6) 2024 the hospital has outsourced the repair of the devices to third-party maintenance companies and has no service contract with getinge.Therefore no service will be performed on this device.The getinge field service technician (fst) has contacted the customer who explained that the machine is constantly in observation and did not have further failures after the event.In communication with the fst, a possible root cause for the failure is that the machine´s battery was previously replaced by a non-original battery.The hospital was informed by the ssu about the risks and responsibilities involving the use of non-genuine batteries.The hospital is unwilling to provide more information.Based on the investigation results the reported failure could be confirmed and the the root cause could be determined as the lifetime of the battery was passed and the replacement was overdue.The review of the non-conformities was performed on (b)(6) 2024 and during the period of (b)(6) 2020 to (b)(6) 2024 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 with s/n: (b)(6) was produced in (b)(6) 2020.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 | v15.Chapter 3.3.4.Check battery capacity every 6 months, at the latest.The battery must be replaced by the authorized technical service every 2 years, at the latest.The battery must be replaced sooner if it cannot be fully charged within 8.5 hours or if the system cannot be operated with the fully charged battery.Chapter 5.6.1.Before starting the application, check the points listed in "check before every use".Before each use, ensure that the batteries are fully charged.If the battery capacity is low an acoustic signal sounds on the device.Chapter 2.2.3.To ensure patient safety, only use tested and approved devices, parts, accessories and disposables.The customer will be informed about the results by the getinge sales and service unit.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18674615
MDR Text Key336298681
Report Number8010762-2024-00078
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K991864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMCP00706291#ROTAFLOW PUMP MODULE
Device Catalogue Number701046405
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2020
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-