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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 DRIVE UNIT, BLUE
Device Problem Erratic or Intermittent Display (1182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2022
Event Type  malfunction  
Event Description
It was reported during an amsect perfusion meeting that the rotaflow flow sensor is losing its capabilities.This affected the displayed flow on the device.The failure occurred during patient treatment.The customer renewed the ultrasonic contact cream and restarted the device to solve the problem.Complaint id: (b)(4).
 
Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.Further information has been requested but has not yet been received.
 
Manufacturer Narrative
It was reported during an amsect perfusion meeting that the rotaflow flow sensor is losing its capabilities.This affected the displayed flow on the device.The failure occurred during patient treatment.The customer renewed the ultrasonic contact cream and restarted the device to solve the problem.No harm to any person occurred.A service technician was on site on 2022-05-17 to check the affected rotaflow (serial# (b)(6).The technician confirmed the reported failure, since the customer was not renewing the ultrasonic contact cream after 48h as described in the instruciton for use (see below).This led to the reported loss of the displayed flow on the device.No malfunction was detected and the device is working as intended.Based on these investigation results the reported failure could be confirmed.The most probable root cause could be determined as dried contact cream, since the user did not renew it.The product in question was produced in 2020-01-08.The review of the non-conformities has been performed on 2022-05-24 for the period of 2020-01-08 to 2022-04-08.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.In order to avoid reoccurrence of the reported failure, the customer was 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 2.2.4 general precautionary measures during use/ 6.2 reapplying ultrasonic contact cream.The ultrasonic contact cream can dry out and impair the functioning of the integrated flow/bubble sensor.In the "free" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message [sig!] appears.In the "stand al" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message [faultbub] appears.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.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.
 
Event Description
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
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key14278144
MDR Text Key290785868
Report Number8010762-2022-00145
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Reporter Country CodeBF
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,Followup
Report Date 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROTAFLOW DRIVE UNIT, BLUE
Device Catalogue Number701022161
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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