MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

Model Number 8100

Device Problem Device Alarm System (1012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Asystole (4442)

Event Date 12/26/2021

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the failure investigation has been completed.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.

Event Description

It was reported that the pump module had a channel disconnect alarm then battery failure.It was noted that the pump module had stopped.Received a copy of the customer's medwatch report from fda which states "in afternoon, nursing noted a pump malfunction (channel disconnect error) ¿ propofol, levophed, and vasopressin were not running.Epinephrine was running in a separate functioning channel.Patient's mean arterial pressure (map's) dropped.It took approximately 30 seconds for nursing to get in the room and turn the channel pumps to turn back on, which the channels then said "battery error" and the channels shut off.With re-initiation of pump, patient's maps did not improve.The patient continued to desaturate and became bradycardic which then progressed to asystole.Resuscitation was not attempted as the patient was made dnr (do not resuscitate) earlier in the day.Given the patient's clinical condition, it cannot be determined to what effect this hastened the patient's death." it was reported that the primary and secondary causes of death were hypoxic respiratory failure secondary to covid pneumonia.

Event Description

It was reported that the pump module had a channel disconnect alarm then battery failure.It was noted that the pump module had stopped.Received a copy of the customer's medwatch report from fda which states "in afternoon, nursing noted a pump malfunction (channel disconnect error) ¿ propofol, levophed, and vasopressin were not running.Epinephrine was running in a separate functioning channel.Patient's mean arterial pressure (map's) dropped.It took approximately 30 seconds for nursing to get in the room and turn the channel pumps to turn back on, which the channels then said "battery error" and the channels shut off.With re-initiation of pump, patient's maps did not improve.The patient continued to desaturate and became bradycardic which then progressed to asystole.Resuscitation was not attempted as the patient was made dnr (do not resuscitate) earlier in the day.Given the patient's clinical condition, it cannot be determined to what effect this hastened the patient's death." it was reported that the primary and secondary causes of death were hypoxic respiratory failure secondary to covid pneumonia.

Manufacturer Narrative

Correction: it was determined through investigation of the returned devices that the initially reported suspect device reported under manufacturer report number 2016493-2022-106373 is a concomitant.Please refer to manufacturer report number 2016493-2022-100366, which captured the correct suspect device per investigation report.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 13548340
• MDR Text Key: 285732764
• Report Number: 2016493-2022-106373
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: (01)10885403810015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100 ALARIS LVP MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Sex: Female