MAUDE Adverse Event Report: CAREFUSION 303,INC. VERSASAFE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 03/29/2014

Event Type  malfunction  

Event Description

Nurse went to administer scheduled medication of sodium phosphate on alaris/carefusion pump.Medication was iv and hung as a secondary.Upon starting medication, it was noticed that the drip for infusion appeared faster than expected.For example, infusion was 120ml to infuse for 4 hours which equals out to be 30cc/hr.It was noticed that the drip that was programmed for 30cc/hr was dripping faster than iv line next to medication that was infusing at 75cc/hr.When na phos was paused to assess iv line, the medication would still drip.Rn also noticed that the drip chamber for primary ivf line was full, which prompted rn to clamp primary bag.When both pumps were paused and primary infusion was clamped neither medication would drip.Due to sodium phosphate bag already being spiked, rn kept primary line clamped which allowed secondary (sodium phosphate) to infuse at correct rate.Note, rn also tried same tubing but in different module attached to carefusion pump and had same issue.

• Brand Name: VERSASAFE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303,INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 3865839
• MDR Text Key: 17294560
• Report Number: 3865839
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: N/A
• Device Catalogue Number: 11499816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 77