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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 GERMAN EU-PLUG ICU
Device Problems Electrical /Electronic Property Problem (1198); Detachment of Device or Device Component (2907)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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.
 
Event Description
It was reported that a rotaflow displayed the error message ¿head error¿.No further information has been received.No information regarding a medical intervention has been received so far.Customer has been asked to provide further information.Complaint id: (b)(4).
 
Event Description
It was reported that a rotaflow displayed the error message ¿head error¿.The failure occurred during priming.In addition it was found during repair that the rf cover for d-sub plug needs to be replaced since the chain is broken.No remedial action has been taken.
 
Manufacturer Narrative
It was reported that a rotaflow displayed the error message ¿head error¿.The failure occurred during priming.In addition it was found during repair that the rf cover for d-sub plug needs to be replaced since the chain is broken.No remedial action has been taken.The affected rotaflow console (serial# (b)(6)) was sent back to manufacturer for repair.It was received on 2022-07-05 and during investigation by the getinge service department on 2022-09-21 the reported failure "head error" could not be reproduced.In addition it was found that the rf cover for d-sub plug needs to be replaced since the chain is broken.A getinge in house technician replaced the rfc (rotaflow console) control board kit (material#70103.4051) and rf cover for d-sub plug (material#70107.3413) on 2022-11-02.After the replacement the device is working as intended.The following most possible root cause could be determined for the head error:  1.The head error is caused by the hot plug.When the device is in operation and the power plug is plugged in or out the head error occurs and the rota flow drive and / or the control board is damaged.As a result the rota flow drive and / or the control board has to be replaced.The failure mode "broken chain of the rf cover for d-sub plug" can be linked to the following most possible root causes according to the rotaflow risk management file.Malfunction or total fail due to mechanical influences, e.G.: 1.Loosening of fastening (wrong installation, aging).2.System falls to ground (transport in non-fixed manner, user routine violation).Based on these investigation results the reported failure could be confirmed.The product in question was produced in 2017-10-01.The review of the non-conformities has been performed on 2022-08-25 for the period of 2017-10-01 to 2022-03-29.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 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 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.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.
 
Manufacturer Narrative
Correction section addtl mfg narrative/corr.Data: unfortunately, there is an error in section addtl mfg narrative/corr.Data that makes the situation contradictory.In the final mdr, sent on 2022-11-09 (mfg report number# 8010762-2022-00109), it was written the following: "the affected rotaflow console (serial#(b)(6) was sent back to manufacturer for repair.It was received on 2022-07-05 and during investigation by the getinge service department on 2022 (b)(6) the reported failure "head error" could not be reproduced." it is, in fact, incorrect that the failure could not be reproduced.The cause of the reported failure in this complaint is ¿hot plug¿.As described in the mentioned section, the control board (material#70103.4051) was replaced by a getinge service technician.We included the word "not" instead of acknowledging the failure.The failure was reproduced and confirmed.Therefore, now section addtl mfg narrative/corr.Data is adapted to correct the contradictory information previously sent.
 
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
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
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MDR Report Key14019220
MDR Text Key288651758
Report Number8010762-2022-00109
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 01/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROTAFLOW GERMAN EU-PLUG ICU
Device Catalogue Number701051702
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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