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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG; TUBING, PUMP, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HQV 3900#ADULT PERF
Device Problem Fluid/Blood Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 11/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).
 
Event Description
Issue with maquet set today in that the one way valve on the red sucker was leaking, as a result i had to chop out the valve to stop this problem and there was around 50-100 mls of blood loss for the patient.(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).Sap trend search was performed based on (failure code 0114 leakage/ other set tube component) which came to following results: 6 additional complaints were recorded which appears reported issues are the same since the last 12 months.Based on the sales figures of the last 12 months following occurrence rate was calculated: 0.14%, which is below 1%.Due to this information no systemic issue could be determined.Maquet cardiopulmonary gmbh requested the product for investigation.The function of the claimed valve was checked with water.When the correct flow direction was provided, the water flows through the valve without leaking to the top of the cap.Also, the function of valve was checked with water in the wrong direction.It immediately leaked at the top of the cap.Since the valve was cut out of the line by the customer, it is not possible to determine whether it was installed correctly.Based on this, complaint could not be confirmed.Valve works within specifications.Device history record was reviewed.There were no references found which are indicating a nonconformance of the product in question.The data is 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
Ref.: #: (b)(4).Customer ref.: na.
 
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Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
MDR Report Key8150502
MDR Text Key130034620
Report Number8010762-2018-00323
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
PMA/PMN Number
K053025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/12/2019
Device Model NumberHQV 3900#ADULT PERF
Device Catalogue Number70105.3616
Device Lot Number92233978
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Initial Date Manufacturer Received 11/13/2018
Initial Date FDA Received12/11/2018
Supplement Dates Manufacturer Received02/22/2019
Supplement Dates FDA Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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