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

Model Number	5163102
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest medical received the suspect device on 7/12/2022.Investigation of the device confirmed the complaint condition.The root cause was determined to be insufficient solvent bonding between the bushing and the tubing.Quest will continue to monitor complaint trending for this complaint condition.Quest has concluded its investigation.
Event or Problem Description
It was reported to quest medical by (b)(6) of an mps disposable set allegedly leaked during the dose of cardioplegia, prior to hot shot.It was confirmed that there were no patient complications.
Additional Manufacturer Narrative
Further investigation of the suspect device was conducted.The investigation concluded that there was no apparent leaks on either the additive or arrest drug lines or cartridges.Testing was performed on the device at 10, 17, and 20 psi and no leaking was noted.Quest could therefore not replicate the reported complaint condition.Quest will continue to monitor complaint trends.

• Brand Name: MPS 3 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: 15170103
• Report Number: 1649914-2022-00020
• Device Sequence Number: 5034851
• Product Code: DTR
• UDI-Device Identifier: 00634624516311
• UDI-Public: 00634624516311
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 11/11/2024
• Device Model Number: 5163102
• Device Lot Number: 64426
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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