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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 2 DELIVERY SET; CPBP HEAT EXCHANGER

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QUEST MEDICAL, INC. MPS 2 DELIVERY SET; CPBP 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 03/24/2023
Event Type  malfunction  
Manufacturer Narrative
Quest medical has not yet completed its investigation of this device.A follow-up report will be filed at the conclusion of its investigation.
 
Event Description
It was reported to quest medical by cosmotec japan of an alleged issue with mps 2 disposable set, product code 5001102.The report stated that there was an alleged blood leak at the pressure sensor of the mps 2 delivery set.It was confirmed that there were no patient complications.
 
Manufacturer Narrative
The suspect device was received by quest medical.Testing of the device at 10psi while submerged underwater revealed bubbles emerging from the diaphragm.The complaint condition of leaking was confirmed.The root cause was determined to be due to a breakdown of the glue path at the diaphragm, likely due to extended priming time.The user is instructed to not prime the device for more than 12 hours in order to avoid this failure mode.Quest has concluded its investigation into this device.Quest will continue to monitor trends for this complaint condition.
 
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Brand Name
MPS 2 DELIVERY SET
Type of Device
CPBP HEAT EXCHANGER
Manufacturer (Section D)
QUEST MEDICAL, INC.
1 allentown parkway
allen TX 75002
Manufacturer (Section G)
QUEST MEDICAL, INC.
1 allentown parkway
allen TX 75002
Manufacturer Contact
brian hedden
1 allentown parkway
allen, TX 75002
9723326311
MDR Report Key16792006
MDR Text Key313962375
Report Number1649914-2023-00015
Device Sequence Number1
Product Code DTR
UDI-Device Identifier00634624501126
UDI-Public00634624501126
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K953838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/21/2023
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
Device Lot Number67375
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 04/24/2023
Initial Date FDA Received04/21/2023
Supplement Dates Manufacturer Received04/24/2023
Supplement Dates FDA Received07/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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