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	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination of the returned device found no anomalies.Testing could not determine a plausible cause for the alleged issue.The reported complaint could not be duplicated and no root cause could be identified.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 hospital biomedical engineer reported for the perfusionist that an issue was encountered with the mps delivery set during use.The report stated that during a procedure the additive and arrest agent cassettes completely emptied out on both sides.The report stated that troubleshooting over the phone determined the issue was with the delivery set rather than with the console.There were no patient complications reported as a result of the alleged issue.The delivery set 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: 6854466
• Report Number: 1649914-2017-00071
• Device Sequence Number: 117756
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/15/2017

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: 06/21/2020
• Device Model Number: 5001102
• Device Lot Number: 0539207E10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/11/2017
• 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