MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS DELIVERY SET WITH ARREST/AGENT CASSETTES AND 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	03/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records for 5001102-as lot #0505176j02 was reviewed and the inspection report showed that no mps disposable set device was found rejected and no specific manufacturing yield issues was reported similar to this complaint condition.Also, the sub assembly pn 801082 lot#0504685355 & 0504685356 were reviewed and no part was rejected for the occlusion or partial occlusion.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 an mps delivery set during use.There were two incidents during the same procedure, with devices from the same lot.Reference manufacturer report number 1649914-2016-00018 for the second incident.This report stated that for this first incident there was no loss of medication because the arrest agent did not get past the point where the medication joins with the blood in the set.The issue occurred while the cross clamp was in place but prior to delivery of the arrest agent.The perfusionist stated that as a result she notified the surgeon who removed the cross clamp while she attempted to troubleshoot.The perfusionist stated that in order to arrest the heart she removed some additive fluid from the additive cassette and replace it with arrest agent and used that additive cassette for the rest of the procedure.There were no complications reported as a result of the alleged event.The device was not returned to the manufacturer for evaluation.

• Brand Name: MPS DELIVERY SET WITH ARREST/AGENT CASSETTES AND 183CM TABLE LINE
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 5618179
• Report Number: 1649914-2016-00017
• Device Sequence Number: 16156750
• Product Code: DTR
• UDI-Device Identifier: 00634624521124
• UDI-Public: 00634624521124
• 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): 03/30/2016

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: 01/03/2019
• Device Model Number: 5001102-AS
• Device Lot Number: 0505176J02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2016
• Initial Report FDA Received Date: 04/28/2016
• 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