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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL INC MPS2 DELIVERY SET; CARDIOPULMONARY BYPASS HEAT EXCHANGER

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QUEST MEDICAL INC MPS2 DELIVERY SET; CARDIOPULMONARY BYPASS HEAT EXCHANGER Back to Search Results
Model Number 5001102
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2023
Event Type  malfunction  
Event Description
The report states that the customer had an issue with product 5001102 during an aortic valve replacement.It was reported that contact between blood and circulating water while using mps2 on a patient.Blood purification was performed during extracorporeal circulation, and no adverse event occurred with the patient.The mps delivery set in question was discontinued and another circuit was used.
 
Manufacturer Narrative
Quest medical is continuing it's investigation.
 
Manufacturer Narrative
The suspect device was received by quest medical on 03/29/2023.Various tests were run to verify the presence of leaking in the disposable set at various pressure levels.The complaint condition could not be replicated.The disposable could not be confirmed as leaking and seems to have been functioning as intended.Quest medical has concluded its investigation of this device.Quest will continue to monitor complaint trends for this complaint condition.
 
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Brand Name
MPS2 DELIVERY SET
Type of Device
CARDIOPULMONARY BYPASS HEAT EXCHANGER
Manufacturer (Section D)
QUEST MEDICAL INC
one allentown pkwy
allen TX 75002
Manufacturer (Section G)
QUEST MEDICAL
one allentown pkwy
allen TX 75002
Manufacturer Contact
gail sauers
one allentown pkwy
allen, TX 75002
9842639140
MDR Report Key16726399
MDR Text Key313154628
Report Number1649914-2023-00014
Device Sequence Number1
Product Code DTR
UDI-Device Identifier00634624501126
UDI-Public00634624501126
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/12/2023
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 03/15/2023
Initial Date FDA Received04/12/2023
Supplement Dates Manufacturer Received03/15/2023
Supplement Dates FDA Received07/21/2023
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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