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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS; TUBING, PUMP, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY GMBH TUBING SETS; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HLS ADULT
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow up mewatch will be submitted when additional information becomes available.
 
Event Description
It was reported from a customer in the us that during cardiohelp veno-veno support with 7.0 hls kit.After one day support, circuit began demonstrating clot and the blood pump began to leak on the pre-membrane side of the circuit from one of the blood inlet ports.Circuit was urgently changed out with new circuit and support was re-initiated.Complaint id: (b)(4).
 
Event Description
Complaint id: (b)(4).
 
Manufacturer Narrative
The reporrted failure "leakage inlet side of pump" occurred during use.The affected product was requested for return for further investigation but we received on 2020-05-28 the information from the ssu that the product is contaminated with covid 19.The product was scrapped by the customer.(see email in the attachment)."the product in question is contaminated with covid-19 and does not need to be returned due to the high risk of spreading the virus".The reported failure "leakage inlet side of pump" is known and already investigated in the complaint (b)(4) with the following outcome: a visual inspection was performed and damages (cracks) were detecteced on the pump housing.During tightness test according lv 201 water leaks out of the cracks.No other abnormalities were detected.The most probable root cause could be determined as rough handling of the device.The reporrted failure "leakage inlet side of pump" occurred during use and could be confirmed.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
TUBING SETS
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
MDR Report Key10066705
MDR Text Key191322618
Report Number8010762-2020-00169
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
PMA/PMN Number
K080592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial,Followup
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHLS ADULT
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/29/2020
Patient Sequence Number1
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