MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 3 ND DELIVERY SET; CBPB HEAT EXCHANGER

Model Number	5ND3102
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest medical received the suspect device on 3/25/22.The sample was investigated and the leaking was confirmed.The root cause was inferred to be due to insufficient solvent bonding between the bushing and the tubing.Quest will continue to monitor complaint trends.Quest has concluded its investigation.
Event or Problem Description
A report was received from a customer stating that there was observed to be an alleged leak in the mps set during surgery.No patient complications were reported.

• Brand Name: MPS 3 ND DELIVERY SET
• Common Device Name: CBPB 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: 14002171
• Report Number: 1649914-2022-00004
• Device Sequence Number: 5206741
• Product Code: DTR
• UDI-Device Identifier: 00634624530348
• UDI-Public: 00634624530348
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: 11/29/2024
• Device Model Number: 5ND3102
• Device Lot Number: 64558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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