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

Model Number	5001102
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was evaluated.There are no other devices of the same lot remaining in inventory for evaluation.The complaint sample was filled with water and manually pressurized to identify any leaks.A small, pinhole leak was observed on the crystalloid side of the device near the blood outlet.The cause of the pinhole is most likely due to warn buffer edge material used during the manufacturing process.The device history records for that lot was reviewed and the inspection report showed that no devices were found rejected and no specific manufacturing yield issues were reported similar to this complaint condition.
Event or Problem Description
The international ((b)(4)) distributor reported an issue encountered by one of their customers while using the mps delivery set.The report stated the procedure was a rethoractomy after avr (aortic valve replacement), and that during the procedure a leak from the blood outlet side of the pump cassette was observed.The report stated that the hospital had to obtain another delivery set from another facility to use for the procedure.The report stated the procedure was successfully completed with no patient complications reported.The device was returned to the manufacturer for evaluation.

• Brand Name: MYOCARDIAL PROTECTION SYSTEM DELIVERY SET
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6100886
• Report Number: 1649914-2016-00057
• Device Sequence Number: 838953
• 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
• Report Date (Section B): 10/18/2016

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: 03/14/2019
• Device Model Number: 5001102
• Device Lot Number: 0510496M05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/14/2016
• 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