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	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to quest medical by (b)(6) hospital of an alleged disposable leak during a case.It was confirmed that there were no patient complications.
Additional Manufacturer Narrative
Quest has not yet recieved the suspect device.Once recieved, quest will begin its investigation.A supplemental report will be filed at the conclusion of the investigation.
Additional Manufacturer Narrative
Quest has not received this device for investigation.Device history records were reviewed for the lot number provided and inspection shows that no specific manufacturing yield issues were reported similar to this complaint condition.Root cause of this complaint condition was unable to be confirmed; however, the cause was inferred to be related to a loos connection, possibly from the luer not being screwed tightly.Quest will continue to monitor complaint trends for this complaint condition.Quest has completed its investigation of this complaint.
Event or Problem Description
It was reported to quest medical by upmc shadyside hospital of an alleged disposable leak during a case.It was confirmed that there were no patient complications.

• 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: 14553150
• Report Number: 1649914-2022-00010
• Device Sequence Number: 4943258
• Product Code: DTR
• UDI-Device Identifier: 00634624530348
• UDI-Public: 00634624530348
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 09/12/2022

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: 03/14/2025
• Device Model Number: 5ND3102
• Device Lot Number: 65415
• 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: 04/29/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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