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

Model Number	5001102
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The foreign distributor ((b)(4)) reported and issue their customer encountered with the mps delivery set during use.The report stated that following the surgical procedure the medical staff removed the delivery set from the console and found blood on the pressure sensor (of the console).The procedure was completed with no problem, but the customer suspects a leak from pressure sensor area of the delivery set.There were no patient complications reported as a result of the alleged event.The device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The complaint sample was attached to an air source and immersed in water and a leak was observed.A review of the device history record did not show any anomalies.The source of the leak is unknown.

• Brand Name: MPS DELIVERY SET
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6700003
• Report Number: 1649914-2017-00054
• Device Sequence Number: 1723117
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

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: Other
• Device Model Number: 5001102
• Device Lot Number: 0519356S02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 07/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention