MAUDE Adverse Event Report: CAREFUSION SMARTSITE 1/2 INFUSION SET

Model Number 2426-500

Device Problems Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)

Patient Problems Fetal Distress (1856); Overdose (1988); Distress (2329); No Code Available (3191)

Event Date 12/20/2014

Event Type  Other  

Event Description

(b)(6) 2014: (b)(6) y/y/o/female, g1, po at (b)(6) weeks her for induction of labor.At 1709: infusion of pre-made pitocin gtt (20mu/500ml ns) started via alaris pump at 2mu/hr with infusion volume set at 450 ml.The pt had a 2nd iv of ns infusing at 125 ml/hr via alaris pump.At 1723: rn was called to room due to fetal tones heard in 90's and questionable deceleration to 60's.Rn repositioned patient and gave a ns bolus (off pump).At 1725: fetal heart tones returned to 125.Rn remained in room and continued to reposition pt and assess fetal heart tones.At 1744: rn discontinued pitocin (pump shut off) and applied o2.At 1810: rn noted that 500 ml bag of pitocin had infused.At 1813: physician was notified and orders for iupc placement given (physician was on-site doing another delivery).At 1843: physician at bedside and vaginal exam of 10 cm and 100% effacement.At 1844: physician orders pt stirrups and for patient to start pushing, fetal heart rate 160's.At 2200: physician discussed options with patient and it was decided to proceed with a c-section.A viable male infant weighing (b)(6) was delivered.Mom and baby transferred to intensive care unit(s) for closer observation.

• Brand Name: SMARTSITE 1/2 INFUSION SET
• Type of Device: SMARTSITE 1/2 INFUSION SET
• Manufacturer (Section D): CAREFUSION; san diego CA
• MDR Report Key: 4376047
• MDR Text Key: 5237432
• Report Number: MW5039845
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/24/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2426-500
• Device Catalogue Number: 2426-500
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PITOCIN 30MU/500ML NS (PREMIXED) - DISTRIBUTOR; (B)(4)
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 78