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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS DELIVERY SET; CPBP HEAT EXCHANGER

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QUEST MEDICAL, INC. MPS DELIVERY SET; CPBP HEAT EXCHANGER Back to Search Results
Model Number 5001102
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The complaint sample was evaluated and was confirmed to be leaking around the diaphragm area and bottom housing.Three additional samples, similar to the complaint sample, were pulled from existing inventory and these samples were leak tested for 24 hours.No leak was observed on any of the additional samples.A dhr review was conducted and there were no manufacturing anomalies associated with the reported complaint condition.The definite root cause of the reported complaint condition is unknown.A potential root cause might be a shift in the diaphragm, which may have created the potential for bond strength degradation and material separation between the diaphragm and the bottom housing components where the leak was observed.Quest will continue to monitor complaint trend.
 
Event Description
A report was received regarding an alleged issue encountered during use of the mps delivery set.The report states that during a procedure, the delivery set leaked when delivering cardioplegia during bypass.The delivery set was changed out without any patient complications resulting from the alleged incident.
 
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Brand Name
MPS DELIVERY SET
Type of Device
CPBP HEAT EXCHANGER
Manufacturer (Section D)
QUEST MEDICAL, INC.
one allentown parkway
allen TX 75002
Manufacturer (Section G)
QUEST MEDICAL, INC.
one allentown parkway
allen TX 75002
Manufacturer Contact
tosan onosode
one allentown parkway
allen, TX 75002
9723326338
MDR Report Key8880750
MDR Text Key162885334
Report Number1649914-2019-00042
Device Sequence Number1
Product Code DTR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 08/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5001102
Device Lot Number0580089A04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2019
Initial Date Manufacturer Received 07/15/2019
Initial Date FDA Received08/09/2019
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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