MAUDE Adverse Event Report: QUEST MEDICAL, INC. Q2 CHECKMATE EXTENSION SET; IV ADMINISTRATION SETS AND EXTENSION SETS

Model Number	9541
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/01/2016
Type of Reportable Event	Serious Injury
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 reported an issue encountered with the fluid delivery device during use.The nurse reported that at the end of the tubing where the 3 check valves come together would not tighten and blood leaked as a result.She mentioned this has happened the last four times they have used this product (no details provided).The report stated that the clinical staff did not immediately notice the blood leak as the procedure was a coronary artery bypass graft and the blood leak occurred under the drape.Follow up with the hospital found that "naci" was being administered through the device at the time of the alleged event.The device was discarded by the hospital and not returned to the manufacturer for evaluation; however, they chose to return an unused device from the same lot to help with the complaint investigation.There were no patient complications reported as a result of the alleged event.
Additional Manufacturer Narrative
Visual examination of the returned device did not find any anomalies.Follow up with the complainant found that it is possible they were not tightening the connections properly per the instructions for use.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.

• Brand Name: Q2 CHECKMATE EXTENSION SET
• Common Device Name: IV ADMINISTRATION SETS AND EXTENSION SETS
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 5758629
• Report Number: 1649914-2016-00032
• Device Sequence Number: 16265958
• Product Code: FPA
• UDI-Device Identifier: 00634624095410
• UDI-Public: 00634624095410
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K800825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2016

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: Physician
• Device Expiration Date: 12/01/2018
• Device Model Number: 9541
• Device Lot Number: 0501205D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2016
• Supplement Report FDA Received Date: 07/01/2016
• 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