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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 ROTAFLOW ENGLISH/US US-PLUG ICU
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2023
Event Type  malfunction  
Event Description
The event occurred in the usa.It was reported that the battery of the rotaflow console does not hold the charge.Furthermore, it was reported that the "low bat alarm occurred during patient treatment.The device was exchanged 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 the usa.It was reported that the battery of the rotaflow console does not hold the charge.Furthermore, it was reported that the "low bat alarm occurred during patient treatment.The device was exchanged with another one without consequences for the patient.No harm to any person has been reported.A getinge field service technician investigated the rotaflow console with s/n (b)(6) and could confirmed the reported failures.The battery was over due for replacement and has reached the end of its useful life, therefore the "low bat" alarm occurred.The root cause for the battery failure could be determined as the lifetime of the battery was passed and replacement overdue.Furthermore it was detected that the battery led does not light.The rf (rotaflow) front panel assembly (article number 701045649) and the batterypack ni-cd 24v 132wh (article number 701017188) has been replaced.The technician attempted to replace the battery and perform preventative maintenance on that rotoflow console a few times before this event occurred but could not access the rotoflow console due to it being in use by the customer.After the replacement the device was working as intended and is back in use.A similar complaint was investigated for the reported failure "led not light" by the getinge life-cycle-engineering (lce).The reported failure was caused most probably by as corrosion.The led could not be activated anymore.The corrosion is probably due to liquid.The liquid could have been entered through the frames of the led displays, which are embedded in the front panel of the rotaflow.Based on the investigation results the reported failures could be confirmed.A review of non-conformities was performed on 2023-12-22, and during the time from 2013-04-24 to 2023-12-22 there are no non-conformities 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 on 2013-04-24.In order to avoid reoccurrence of the reported failure "battery failed (life time due)", 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.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.
 
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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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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key18563266
MDR Text Key333468710
Report Number8010762-2024-00044
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 01/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROTAFLOW ENGLISH/US US-PLUG ICU
Device Catalogue Number701051712
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2013
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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