MAUDE Adverse Event Report: BD / CAREFUSION 303, INC. BD ALARIS IV PUMP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Bradycardia (1751); Fetal Distress (1856); Reaction to Medicinal Component of Device (4574)

Event Date 10/11/2021

Event Type  malfunction  

Event Description

Pump running faster than what`s being programmed: pitocin infusing on patient at 1ml/hr.(1mu/min).Pt noted to have tetanic uterine contraction lasting >5min with prolonged fetal deceleration in hr.Multiple staff to bedside.Pt's uterus firm to palpation.Pitocin turned off.Iv pump channel off but pitocin bag noted to still be dripping slowly.Greater volume appeared to be missing from the bag that what should have been administered.Iv tubing clamped and disconnected from patient.Pt also had lactated ringers infusing on same iv pump on another channel.Entire iv pump changed.Later original pump checked by writer and patient's nurse.Pitocin programmed at 1ml/hr.To infuse in medicine cup to check volume.Initially pitocin appeared to be dripping appropriately.After approx 5 min, pitocin began dripping rapidly into cup and overflowed a 30ml medicine cup and spilled over onto the floor.Pump was programmed correctly and volume infused on pump read.07ml.Pump taken out of service and pitocin and tubing left in channel for biomed to check in the morning.Clinical engineering reviewed pump and was able to replicate the error: free flow noted when low volume infusing, no issues noted with higher volume infusion.Fda safety report id # (b)(4).

• Brand Name: BD ALARIS IV PUMP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD / CAREFUSION 303, INC.
• MDR Report Key: 12639615
• MDR Text Key: 276647287
• Report Number: MW5104658
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Weight: 67