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	12/07/2016
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.The stopcock is obtained from an outside supplier, who was notified and issued a scar to address the issue.The device history records for the applicable lot of product was reviewed and the inspection report showed that none of the devices were found rejected and no specific manufacturing yield issues were reported similar to this complaint condition.There are no devices of this lot remaining in inventory for evaluation.
Event or Problem Description
The hospital perfusionist reported an issue encountered with the mps delivery set during use.The report stated that prior to going on pump (bypass on heart/lung machine) she observed the yellow arrest-agent stopcock had a very slow leak.The report stated this was found while the perfusionist was administering cardioplegia and also while the unit was not delivering cardioplegia (that is, it was a continuous leak).The leaked fluid was potassium only with the estimated volume lost was 5 mls.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 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: 6210300
• Report Number: 1649914-2016-00070
• Device Sequence Number: 16393332
• Product Code: DTR
• UDI-Device Identifier: 00634624521124
• UDI-Public: 00634624521124
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/07/2016

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: 08/24/2019
• Device Model Number: 5001102-AS
• Device Lot Number: 0519246G08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 12/28/2016
• 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