MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP ADMINISTRATION SET; SET,ADMINISTRATION, INTRAVASCULAR

Model Number 2421-0500

Device Problem Insufficient Information (3190)

Patient Problems Apnea (1720); Cardiopulmonary Arrest (1765)

Event Type  Injury  

Manufacturer Narrative

Patient was an infant - preemie.An incomplete date of event of (b)(6) 2019 was provided in medwatch.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Concomitant medical products: lot 18018388 is not a valid lot number.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "infant went apneic.No response to stimulation.Intubated.See code sheet for times and medications given per dr.Per code emergency drug sheet at bedside." an incomplete date of event of (b)(6) 2019 was provided.Although requested, no further details were provided by the customer for this event.

Event Description

Customer advocacy received a copy of the customer's medwatch report from the fda which states, "infant went apneic.No response to stimulation.Intubated.See code sheet for times and medications given per dr.Per code emergency drug sheet at bedside." an incomplete date of event of (b)(6) 2019 was provided.Although multiple attempts made for event details there was no further information provided by the customer or patient impact.At this time.

Manufacturer Narrative

Lot 18018388 for suspect model 2421-0500 was populating as 8100-032.Product grid revised to remove lot - supplemental created.

Manufacturer Narrative

Supplemental created due to product grid revised from return expected to no product received and add b5:although multiple attempts made for event details there was no further information provided by the customer or patient impact.At this time.No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.

Event Description

Although multiple attempts made for event details there was no further information provided by the customer or patient impact at this time.

• Brand Name: ALARIS PUMP ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9290577
• MDR Text Key: 165438894
• Report Number: 9616066-2019-03167
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019149
• UDI-Public: 7613203019149
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 2421-0500
• Device Catalogue Number: 2421-0500
• Device Lot Number: 18018388
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/14/2020; 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 82113E, 20028E, 8100, 8015, THERAPY DATE UNKNOWN; 82113E, 20028E, 8100, 8015, THERAPY DATE UNKNOWN
• Patient Outcome(s): Life Threatening; Required Intervention