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

Model Number	5001102
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.

• Brand Name: MPS 2 DELIVERY SET
• Common Device Name: 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 Key: 16792006
• Report Number: 1649914-2023-00015
• Device Sequence Number: 5679272
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2025
• Device Model Number: 5001102
• Device Lot Number: 67375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown