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	12/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint condition was confirmed.A leak was found between the clear housing and the yellow handle diverter of the stopcock in the delivery position.The stopcock is obtained from an outside supplier, who was notified and issued a scar to address the 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.There were no more devices of this same lot remaining in inventory for evaluation.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 international distributor ((b)(4)) reported an issue their customer encountered while using the delivery set.The report stated that during an emergency surgery, the backside of the three-way stopcock of the arrest pouch containing potassium leaked.The report stated the clinicians decided to use the delivery set to complete the procedure.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: 6302630
• Report Number: 1649914-2017-00004
• Device Sequence Number: 10772445
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2017

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: 05/13/2019
• Device Model Number: 5001102
• Device Lot Number: 0513606Y07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 02/03/2017
• 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