MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 7N8399

Device Problems Break (1069); Crack (1135); Material Protrusion/Extrusion (2979)

Patient Problem Tachycardia (2095)

Event Date 08/14/2019

Event Type  malfunction  

Event Description

Patient due for iv veletri cartdridge and tubing to be changed.This rn primed line and connected to patient.Pump infusing without issue, or alarms.Patient then stated to this nurse that he felt like the pump wasn't running (per pt, based off an experience he had at home prior to admission)and his heart rate felt faster.(hr 115-120).Patient and this rn inspected all clamps and found them to all be open.This rn then noted that the point in which the cap/clave coming from patient's hickman and the tubing from the cadd pump appeared crooked.Rn and pt disconnected the two to try to re-connect.Once disconnected it was noted that the cap/clave from the hickman was cracked/broken, with the rubber inner part protruding out.Pieces of plastic were noted to be broken off into the cadd pump tubing, making it impossible to connect to a new cap/clave.This rn obtained a new cap/clave, used the pt's second pump (which still had prior cartridge and tubing in place), primed new cap/clave and connected pt back to infusion within approx.2 min.It is believed this was a faulty cap/clave.Dressing and cap had been changed per weekly discharge change.

• Brand Name: ONE-LINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 9081635
• MDR Text Key: 158982293
• Report Number: 9081635
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7N8399
• Device Catalogue Number: 7N8399
• Device Lot Number: (10)UR18K30013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1