MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ZR; SALINE, VASCULAR ACCESS FLUSH

Lot Number 3130571

Device Problems Failure to Infuse (2340); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 10/09/2017

Event Type  malfunction  

Event Description

7 syringes from the same lot failed.These normal saline flush syringes are connected to microbore tubing and then the patient's iv to push the medications through the tubing.Each will start infusing on the pump then trigger an alarm for "occluded patient side" which signals that there is higher than acceptable pressure going into the patient's vascular access device.This places the patient at an increased risk of infection due to accessing the line multiple times and clotting of the line related to the infusion stopping while the pump is beeping if the nurse cannot get to the pump.It is also consumes a lot of the nurses' time to answer a beeping pump and replace the syringe multiple times for each medication given.

• Brand Name: ZR
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7052985
• MDR Text Key: 92791970
• Report Number: 7052985
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2019
• Device Lot Number: 3130571
• Other Device ID Number: 10363807100305
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALARIS CAREFUSION INFUSION PUMP AND SYRINGE MODULE