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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
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MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number MCP00706035#ROTAFLOW ENGLISH/US US-PLUG
Device Problems Pumping Stopped (1503); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/02/2023
Event Type  malfunction  
Manufacturer Narrative
The event occurred in the us.It was reported that on the rotaflow console the error message "low bat" was displayed and the unit shut down during use on patient.The device was exchanged with another device with no consequences for the patient.No harm to any person has been reported.The affected rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and the reported failure could not be confirmed.The batterypack ni-cd 24v 132wh (rfc) (article number 701017188) has been replaced as the battery replacement was one month overdue.The device is working as intended and is back in use.Base on the investigation results the reported failure "low bat" and shut down during use" could not not be confirmed.However, a probable root cause could be that the battery has reached the end of its useful life.The lifetime of the battery was passed and the replacement overdue.The review of the non-conformities was performed on 2023-10-04 and during the period of 2017-09-11 to 2023-10-04 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 affected rotaflow console was produced in 2017-09-11.In order to avoid reoccurrence of the reported failure, the customer will be informed by the sales and service unit 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.Leave the mains circuit breaker at the rear of the rotaflow console switched on.Otherwise the batteries will not be charged.Make sure that the "battery charging" lamp lights up during charging.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 2.2.4 general precautionary measures during use if the pump stops during an application, the blood flow will be interrupted and supply to the patient will cease.Eliminate the cause of the pump stop and start the pump again as soon as possible.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
The event occurred in the us.It was reported that on the rotaflow console the error message "low bat" was displayed and the unit shut down during use on patient.The device was exchanged with another device with no consequences for the patient.No harm to any person has been reported.Complaint id: (b)(4).
 
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Brand Name
HEART LUNG MACHINE
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key17947480
MDR Text Key325814720
Report Number8010762-2023-00502
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K991864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMCP00706035#ROTAFLOW ENGLISH/US US-PLUG
Device Catalogue Number701043292
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2017
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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