MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK TRANSFER SET; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 04/20/2018

Event Type  malfunction  

Event Description

Rn spiking unit of blood at patient bedside.While spiking blood, blood tubing spike dislodged from the blood tubing.Luckily the spike did not fully penetrate the blood and the rn was not exposed to the blood.Tubing and packaging placed in an office for review.

• Brand Name: CLEARLINK TRANSFER SET
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 7493778
• MDR Text Key: 107586608
• Report Number: 7493778
• Device Sequence Number: 1
• Product Code: NEP
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Other Device ID Number: (10)DR18B09O15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR