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	01/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; however, this is a known issue that has occurred in other complaints.A scar has been issued to the supplier of the stopcock.Review of the device dhr did not find any anomalies.There were no devices of this same lot remaining in inventory for analysis.
Event or Problem Description
The hospital perfusionist reported an issue encountered with the delivery set.The report stated that the device had a leak at the stopcock of the arrest agent cassette.The report stated the issue was discovered prior to going on bypass, and another set was opened and used for the procedure instead.There were no patient complications reported as a result of the alleged issue.The device was not returned to the manufacturer for evaluation.

• 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: 6307398
• Report Number: 1649914-2017-00006
• Device Sequence Number: 635181
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K953838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2017

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 Expiration Date: 11/07/2019
• Device Model Number: 5001102
• Device Lot Number: 0523416N04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 02/07/2017
• 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