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

Model Number	5ND3102-AS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been received.However, quest has not yet completed its investigation.A supplemental report will be filed at the conclusion of the investigation.
Event or Problem Description
A report was received from baylor university medical center.The report stated that an mps 3nd delivery set was set up and primed with no issue.However, during the surgery, an alleged leak was noted one inch down from the blood inflow stem of the pouch.
Additional Manufacturer Narrative
The sample was received by quest medical.Investigation was performed on the sample and the leaking was confirmed on the blood side of the pump cassette.The root cause is believed to be related to a weak weld on the pump cassette.Quest will continue to monitor this complaint trend.Quest has concluded its investigation of this complaint sample.
Event or Problem Description
A report was received from baylor university medical center.The report stated that an mps 3nd delivery set was set up and primed with no issue.However, during the surgery, an alleged leak was noted one inch down from the blood inflow stem of the pouch.

• 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: 14251314
• Report Number: 1649914-2022-00007
• Device Sequence Number: 4159215
• Product Code: DTR
• UDI-Device Identifier: 00634624530379
• UDI-Public: 00634624530379
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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: 04/14/2024
• Device Model Number: 5ND3102-AS
• Device Lot Number: 62206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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