MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE; PUMP, INFUSION

Model Number 8100

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Therapeutic Response, Increased (2272)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Although requested, the affected device has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

Received a copy of the customer's medwatch report from the fda which states, "alaris iv pump set up with iv infusion of oxytocin for ob patient in labor.The rate was set at 2cc/hour and the "start" button pushed.Rn examined the iv bag of oxytocin and noted that the medication was being "bolused" into the patient.The infusion was stopped immediately, and the fetal heart rate had a twelve minute prolonged deceleration.A terbutaline injection was given to the mother.Apgars of baby were 7 and 8.Baby and mother discharged two days later.".

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 6431742
• MDR Text Key: 70778736
• Report Number: 2016493-2017-00210
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PRI TUBING,8015, THERAPY DATE (B)(6) 2017
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR