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

Model Number	5001102
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial evaluation of the returned device found no leak on any part of the sample returned.The sample was then connected to an air source at 5psi and performed a dunk test.Again, no leaking was observed.The sample was inflated with air and clamped at all open ends and left for an hour in tray full of water to identify any leaks.Again, no leak was observed.The same process was repeated for the cassettes and left for an hour in tray full of water to identify any leak.The additive cassette was substantially less inflated than the arrest cassette indicating a leak.Under high pressure of 10psi the additive cassette leaked at the weld joint on the top of the cassette.The root cause was not determined.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Event or Problem Description
The sales representative reported an issue encountered by the hospital perfusionist with the mps delivery set.The report stated the perfusionist discovered that the line had a pin-hole leak that was capable of leaking blood and aspirating air.She stated the line was changed out before any air was delivered to the patient.There were no patient complications reported as a result of the alleged issue.The device was 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: 6840453
• Report Number: 1649914-2017-00068
• Device Sequence Number: 68246
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (Y/N): N
• 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): 08/03/2017

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: 0533427A06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 09/01/2017
• 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