MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 3 ND WATER HOSE KIT; CPBP HEAT EXCHANGER

Model Number	5303030
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest is still pending receipt of the alleged device.Quest will file a supplemental report at the completion of the investigation.
Event or Problem Description
It was reported to quest medical of an alleged issue with water hose connector 5303030.Per the report, after the induction dose, the water line hose connector disconnected, spraying water into the sterile field.Instruments had to be changed out and the patient was put on additional antibiotics.No patient complications were reported.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.Communication with the user facility, communications with the user facility of the device determined that the failure was likely due to user error when positioning the connection of the tube.It was noted that there were no patient complications.
Event or Problem Description
It was reported to quest medical of an alleged issue with water hose connector 5303030.Per the report, after the induction dose, the water line hose connector disconnected, spraying water into the sterile field.Instruments had to be changed out and the patient was put on additional antibiotics.No patient complications were reported.

• Brand Name: MPS 3 ND WATER HOSE KIT
• 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: 15136073
• Report Number: 1649914-2022-00019
• Device Sequence Number: 12089227
• Product Code: DTR
• UDI-Device Identifier: 20634624530335
• UDI-Public: 20634624530335
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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 Model Number: 5303030
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown