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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 MCP00706291#ROTAFLOW PUMP MODULE
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2023
Event Type  malfunction  
Event Description
The event occurred in china.It was reported that on (b)(6) 2023, the customer was using the rotaflow console and the ac power was disconnected due to the transport of the patient.The ¿low battery alarm¿ occurred after a short time.After the machine was exchanged, the charging was checked.The charging voltage was 26.3v (battery is fully charged between 27,4 and 20,0 volt), and the battery was charged continuously for more than 8 hours.The charging indicator light goes out, but the battery voltage is only 24.8v.Discharge the affected battery and charge it on another rotaflow console.At this time, the charging is very fast, reaching 26.2v immediately, and it is in the charging state, so it is judged that the power supply board is faulty (spare part number: 701011675) and needs to be replaced.The device is out of use.No harm to any person has been reported.Complaint id: (b)(4).
 
Manufacturer Narrative
The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.
 
Manufacturer Narrative
The event occurred in china.It was reported that on (b)(6) 2023, the customer was using the rotaflow console and the ac power was disconnected due to the transport of the patient.The ¿low battery alarm¿ occurred after a short time.After the machine was exchanged, the charging was checked.The charging voltage was 26.3v (battery is fully charged between 27,4 and 20,0 volt), and the battery was charged continuously for more than 8 hours.The charging indicator light goes out, but the battery voltage is only 24.8v.Discharge the affected battery and charge it on another rotaflow console.At this time, the charging is very fast, reaching 26.2v immediately, and it is in the charging state, so it is judged that the power supply board is faulty (spare part number: 701011675) and needs to be replaced.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 technician was able to reproduce the reported failure.The mcp00702711#power supply board for rfc (article number 701011675) has been replaced.After the replacement the device is working as intended and is back in use.A similar complaint was investigated for the reported failure in getinge life-cycle-engineering (lce) and the reported failure was caused most probably by a defect diode d6 on the power supply board that led to the reported failure.Based on the investigation results the reported failure could be confirmed.The rotaflow console in question was produced in 2022 (b)(6).A device history record (dhr) review was performed on 2023 (b)(6).There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.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.
 
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 Key18071952
MDR Text Key327376578
Report Number8010762-2023-00542
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,Followup
Report Date 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2023
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 Received12/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2022
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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