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

Model Number	2421-0500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Apnea (1720); Cardiopulmonary Arrest (1765)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional Manufacturer Narrative
Lot 18018388 for suspect model 2421-0500 was populating as 8100-032.Product grid revised to remove lot - supplemental created.
Additional 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 or Problem 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
• Common Device Name: SET,ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9290577
• Report Number: 9616066-2019-03167
• Device Sequence Number: 2172583
• Product Code: FPA
• UDI-Device Identifier: 07613203019149
• UDI-Public: 7613203019149
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/14/2020; 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 82113E, 20028E, 8100, 8015, THERAPY DATE UNKNOWN; 82113E, 20028E, 8100, 8015, THERAPY DATE UNKNOWN
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention