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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENTOR, CARDIOPULMONARY BYPASS; OXYGENATOR, CARDIOPULMONARY BYPASS
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MAQUET CARDIOPULMONARY AG OXYGENTOR, CARDIOPULMONARY BYPASS; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD30000-USA#Q
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).(b)(4).Device was requested but not yet received.
 
Event Description
According to the customer: the perfusionist spotted a large clot in the outlet of the pediatric quadrox.More information of the territory manager received: spoke with the director of perfusion at (b)(6) hospital and he told me that he thinks the issue is with the heparin that they are receiving from their pharmacy.I think they changed suppliers and they are looking into the products efficacy.The account would like getinge to look at the oxygenator just to rule out any manufacturing issues.The customer changed out the entire circuit.No harm to the patient was reported.(b)(4).
 
Manufacturer Narrative
Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa, 45 barbour pond drive, wayne, nj 07470.Contact person- (b)(4).The product was requested for return to the manufacturer for laboratory investigation.The sample was investigated in the laboratory of the manaufacturer.A quadrox-id pediatric with tubes was returned.The sample was contaminated.Tubes removed and disposed of.Oxygenator flushed with water.Clots could be confirmed on the blood outlet side.Sample was cleaned with sodium hypochlorite.Visual inspection of the blood outlet cover and the connector was performed, no other abnormalities were found.Thus the failure could be confirmed.The most probable cause of clotting in this case cold be according to the statement of the customer that they think the issue is with the heparin that they are receiving from their pharmacy.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
 
Event Description
Internal reference: (b)(4).
 
Event Description
Internal reference: (b)(4).
 
Manufacturer Narrative
Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- (b)(4).
 
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Brand Name
OXYGENTOR, CARDIOPULMONARY BYPASS
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
MDR Report Key7588005
MDR Text Key111151323
Report Number8010762-2018-00207
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K100278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/10/2020
Device Model NumberBEQ-HMOD30000-USA#Q
Device Catalogue Number701050330
Device Lot Number70121668
Date Manufacturer Received05/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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