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

Model Number	5001102
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot number 0601210m08 was reviewed, and the inspection report shows that no specific manufacturing yield issues were reported similar to this complaint condition.In addition, as the reported issue is related to the heat exchanger, sub assembly device history record for 801082 lot number 0599680057 and 0600670058 were also reviewed, and the inspection report shows that no specific manufacturing yield issues were reported similar to complaint condition.An investigation could not be completed because the alleged sample was not returned.
Event or Problem Description
An incident was reported where the reporter emailed a picture to customer service.The reporter said that they noticed blood migration into the heat exchanger in a way they had not seen before.There were no patient complications resulting from the alleged incident.

• Brand Name: MPS DELIVERY SET
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen, tx
• MDR Report Key: 10467430
• Report Number: 1649914-2020-00031
• Device Sequence Number: 2567783
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2020

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: No Information
• Device Expiration Date: 03/10/2023
• Device Model Number: 5001102
• Device Lot Number: 0601210M08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1