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

Model Number	5ND3102
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged device sample was not returned to quest medical and the complaint condition could not be confirmed.A review of the device history record for the alleged lot revealed no manufacturing issues.Quest will file a supplemental report should any additional information become available and will continue to monitor this complaint trend.
Event or Problem Description
It was reported to quest medical of an mps delivery set ((b)(4)) that was allegedly leaking during a case.It was confirmed that there were no patient complications and the case was able to be completed without issue.

• Brand Name: MPS 3 ND 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: 15135985
• Report Number: 1649914-2022-00017
• Device Sequence Number: 5234416
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: 04/07/2025
• Device Model Number: 5ND3102
• Device Lot Number: 65722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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