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	Blood Loss (2597)
Date of Event	02/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual examination of the device found a pinhole leak at the blood side inlet area on the weld seam.This was caused most likely by a worn, rough-edged buffer transfer to the pump cassette at the weld seam.A cpar has been issued to investigate and address this issue.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.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.It was reported that the delivery set leaked where the connector enters the pouch on the left hand side.Follow up with the complainant found that there was an estimated 150-200 ml blood loss due to the leak.They stated that it was found while the patient was on bypass just before the cross clamp was placed.The perfusionist reported they saw the leaked blood under the mps console, informed the surgeon, clamped the lines and investigated to find the source of the leak.There were no patient complications reported as a result of the alleged event.The device was returned to the manufacturer for analysis.

• 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: 5520698
• Report Number: 1649914-2016-00007
• Device Sequence Number: 593553
• Product Code: DTR
• UDI-Device Identifier: 00634624521124
• UDI-Public: 00634624521124
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K041979
• 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): 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 12/03/2018
• Device Model Number: 5001102-AS
• Device Lot Number: 0504025D04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2016
• Initial Report FDA Received Date: 03/23/2016
• 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