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

Model Number 8100

Device Problems Break (1069); Corroded (1131); Excess Flow or Over-Infusion (1311)

Patient Problems Hypoxia (1918); Hypervolemia (2664)

Event Date 03/26/2023

Event Type  Injury  

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 a pump module had an over infusion on two different patients on two different days.During the first event, a bag of 0.45% sodium chloride fluids were programmed to infuse at a rate of 50ml/hr on (b)(6) 2023 at 1524.Clinician scanned new 1 liter bag of fluid to administer on (b)(6) 2023 at 1234.Around 1530 clinician was in patient's room and noticed the 1 liter bag was near empty; she confirmed the pump was set to 50ml/hr-clinician and nurse practitioner witnessed.There was patient involvement however patient impact is unknown.The second event is captured under pr 7560383.

Manufacturer Narrative

Omit: b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available, a device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.

Event Description

It was reported a pump module had an over infusion on two different patients on two different days.During the first event, a bag of 0.45% sodium chloride fluids were programmed to infuse at a rate of 50ml/hr on 3/25/23 at 1524.Clinician scanned new 1 liter bag of fluid to administer on 3/26/23 at 1234.Around 1530 clinician was in patient's room and noticed the 1 liter bag was near empty; she confirmed the pump was set to 50ml/hr-clinician and nurse practitioner witnessed.Patient has a history of end stage renal failure and was fluid overloaded following the over infusion.Stat labs were drawn and iv lasix ordered post event.Patient declined later in the shift-several hours post infusion with increasing oxygen demands and ultimately was transferred to higher level of care in the medical intensive care unit (micu) where patient was intubated in the setting of hypoxia.Patient outcome is still pending at time of this entry as patient is currently still in the micu.The second event is captured under pr (b)(4).

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): 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: 16774249
• MDR Text Key: 313629845
• Report Number: 2016493-2023-148718
• 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
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• 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: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2736-2020
• Patient Sequence Number: 1
• Treatment: 8015
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 59 KG