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

Model Number 9541

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2015

Event Type  malfunction  

Event Description

The hospital ambulatory surgery supervisor (rn) reported an issue encountered with the q2 checkmate extension set.She reported that the crna observed that when patients are taken back into the or, there are issues with the iv ports becoming disconnected.The crna had told her this occurs on the anesthesia tubing line, and not the one that connects to the continuous iv tubing.The report stated they typically will discover the issue because fluids are leaking or blood is seen in the tubing.The fluids being administered at the time would be propofol, tranexamic acid, or some antibiotics.There have not been any patient complications reported as a result of the alleged malfunction.The hospital shipped a sample to the manufacturer for evaluation.

Manufacturer Narrative

Visual evaluation of the device sample did not find any anomalies or cause for the reported complaint.The user had confirmed they were not tightening the cap after connecting the tubing to the checkmate.The instructions are indicated in the ifu.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
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 5173761
• MDR Text Key: 29824380
• Report Number: 1649914-2015-00093
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/31/2018
• Device Model Number: 9541
• Device Lot Number: 0488075A03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention