MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS DELIVERY SET WITH 183CM TABLE LINE; CPBP HEAT EXCHANGER

Model Number	5001102-AS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.
Event or Problem Description
The hospital perfusionist reported an issue encountered with the mps delivery set during use.The report only stated that the disposable device leaked.There were no other details provided.The device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
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.Visual examination of the returned device found no patient blood or residue, so the alleged issue may have been found during system priming prior to start of the procedure.Examination under magnification found that the adhesive path at the bubble trap area had a void or there was not sufficient adhesive applied in that area.The device failed blood circuit pressure decay testing and confirmed the alleged complaint condition.

• Brand Name: MPS DELIVERY SET WITH 183CM TABLE LINE
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 5934559
• Report Number: 1649914-2016-00044
• Device Sequence Number: 18954417
• Product Code: DTR
• UDI-Device Identifier: 00634624521124
• UDI-Public: 00634624521124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/07/2016

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: 06/02/2019
• Device Model Number: 5001102-AS
• Device Lot Number: 0515336E03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2016
• Supplement Report FDA Received Date: 10/19/2016
• 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