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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION ONE-LINK SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameONE-LINK
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake IL 60073
MDR Report Key9081635
MDR Text Key158982293
Report Number9081635
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received09/18/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7N8399
Device Catalogue Number7N8399
Device Lot Number(10)UR18K30013
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/23/2019
Event Location Hospital
Date Report to Manufacturer09/18/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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