MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 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	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to quest medical of an allegedly leaking mps delivery set.It was confirmed that there were no patient complications.
Additional Manufacturer Narrative
An investigation on the suspect device is unable to be performed, as the device was discarded after the procedure.A review of the production records from the sample's lot was performed and no anomalies in the manufacturing process were noted.The complaint condition could not be confirmed.Quest will continue to monitor complaint trends for the reported condition.Quest has concluded its investigation of this complaint.

• Brand Name: MPS 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: 15442565
• Report Number: 1649914-2022-00021
• Device Sequence Number: 14845061
• Product Code: DTR
• UDI-Device Identifier: 00634624530348
• UDI-Public: 00634624530348
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: 03/08/2025
• Device Model Number: 5ND3102
• Device Lot Number: 65386
• 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: 08/26/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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