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

Model Number	8100
Medical Device Problem Codes	Break (1069); Contamination (1120); Corroded (1131); Crack (1135); Peeled/Delaminated (1454); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported by the customer that the nurse programmed an infusion of magnesium sulfate for one hour.A little after the one hour mark, they noticed the pump was not beeping and went to check on the patient.The nurse noticed the top of the tubing was dry/empty while the lower half of the tubing, below the chamber and sensor, was also dry; stating there was only fluid 2-3 inches from the piv.The pump module had to be stopped before it infused air into the patient.The safeguard did not go off and the air made it past the sensor.There was patient involvement, but no harm.
Event or Problem Description
It was reported by the customer that the nurse programmed an infusion of magnesium sulfate for one hour.A little after the one hour mark, they noticed the pump was not beeping and went to check on the patient.The nurse noticed the top of the tubing was dry/empty while the lower half of the tubing, below the chamber and sensor, was also dry; stating there was only fluid 2-3 inches from the piv.The pump module had to be stopped before it infused air into the patient.The safeguard did not go off and the air made it past the sensor.There was patient involvement, but no harm.
Additional Manufacturer Narrative
Omit: b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.Additional information: device eval by manufacturer? , imdrf annex a,g,b,c,d codes and manufacturer narrative.A device history record, complaint history review, and risk review on failure modes are performed on each device with reportable malfunction(s) along with other methods of investigation as coded in section h6 of this mdr report.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.Investigation summary: the complaint of the pump module was not beeping and had to be stopped before it infused air into the patient was not confirmed during testing.Laboratory testing performed on the source pump module¿s air in line (ail) detection system found the device was detecting air for both single air bolus and accumulated air bolus within specification.However, the housing of the ail sensor assembly was found to be broken on the rear side of the part of the suspect pump module s/n (b)(6).The event date was reported as 20 march 2025; time was not reported.Review of the pcu and pump module error log showed no errors were recorded on the reported event date.The pump module event log showed the device in use on 19 march 2025 attached to the returned pcu s/n (b)(6) as channel b.The air in line setting for single air bolus was set to 250 l with accumulated air enabled.On (b)(6) 2025 at 7:03 pm the user selected guardrails drugs (primary infusion).The user programmed the drugid 494 (magnesium sulfate 1 gram/100 ml), with a concentration of 0.01 gram/ml, rate of 100 ml, volume to be infused (vtbi) of 100 ml with an expected duration of 1 hour.The infusion started with a primary volume infused (pvi) of 0 ml.At 8:02 pm the pump module was channeled off with a total volume infused of 97.9 ml.There are multiple smaller single air bolus settings (50 microl, 75microl, 125 microl, 175microl, 250 microl) available to the customer, if more sensitivity is desired in air in line detection.However, the profile guardrails may override individual system configuration settings.The system was being used for treatment purposes as intended per 21 cfr 820.198(d)(2).Note to repair center: device was opened for investigation, please re-torque all screws.Repair center should follow their normal processing of the device, looking for any incidental issues prior to returning it to the customer.Dchu will not cover the costs associated with any incidental findings or physically abused components.Root cause: the probable cause of the report indicating that the pump module was not beeping and had to be stopped before it infused air into the patient was not identified.Laboratory testing showed that the air in line (ail) sensor was detecting air within specification; however, the housing of the ail sensor assembly was found to be broken on the rear side of the part.Note that this report lists imdrf annex a0404,a0401, a040506, a1801, a040502, g0301201, g02017, g0204002, g04067, g04037, c07, c23, c0601, d15, d11, d01codes not associated with the reported event but identified as reportable malfunctions observed on the device during investigation are unrelated to the reported issue.These other failures presumptively did not cause or contribute to the reported issue.

• Brand Name: ALARIS SYSTEM
• Common Device Name: 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: 21871446
• Report Number: 2016493-2025-74631
• Device Sequence Number: 15428743
• Product Code: FRN
• UDI-Device Identifier: 10885403211423
• UDI-Public: (01)10885403211423(11)081022
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K133532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2718-2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015
• Patient Sex: Unknown