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

Model Number	8120
Medical Device Problem Codes	Use of Device Problem (1670); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient controlled analgesia pump module was programmed for a continuous infusion of hydromorphone at 0.4mg/hr, in addition to a bolus of 0.2mg.However, the md order specified 0mg for the continuous infusion.The customer also noted that the incident was "already cleared" based on the infusion provided but, "it seems that there may have been an issue with how the pca pump was programmed (possibly operator error), leading to a discrepancy between the md order and the pump settings." there was patient involvement but no harm.
Additional Manufacturer Narrative
The actual date of event is unknown.A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.The event logs have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation 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 that the patient controlled analgesia pump module was programmed for a continuous infusion of hydromorphone at 0.4mg/hr, in addition to a bolus of 0.2mg.However, the md order specified 0mg for the continuous infusion.The customer also noted that the incident was "already cleared" based on the infusion provided but, "it seems that there may have been an issue with how the pca pump was programmed (possibly operator error), leading to a discrepancy between the md order and the pump settings." there was patient involvement but no harm.
Additional Manufacturer Narrative
Correction: pma / 510(k)# 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 that the patient controlled analgesia pump module was programmed for a continuous infusion of hydromorphone at 0.4mg/hr, in addition to a bolus of 0.2mg.However, the md order specified 0mg for the continuous infusion.The customer also noted that the incident was "already cleared" based on the infusion provided but, "it seems that there may have been an issue with how the pca pump was programmed (possibly operator error), leading to a discrepancy between the md order and the pump settings." there was patient involvement but no harm.
Additional Manufacturer Narrative
Omit: c20 - no findings available, d15 - cause not established.Additional information: imdrf annex a, b, c, d, g codes and manufacturer narrative.The actual date of event is unknown.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.Investigation summary: the report of the pca programming error was confirmed through event log review and is being attributed to user error.Inspection, log review and laboratory testing of the devices could not be performed because they were not returned for investigation.External inspection of the suspect devices could not be performed because they were not returned for investigation.The suspect pc unit (pcu), pca module, data set and administration set were not returned for investigation.Although the facility did not report the exact date and time of the event, log analysis confirmed that the programming of the suspect pca occurred on 18nov2025 at 6:49 pm.The data showed that the clinician inserted a bd 30 ml syringe and selected guardrails drug id 169 (suspected to be hydromorphone) with the infusion mode set to pca dose only.All recorded infusions were programmed as pca dose only infusion and not as a continuous infusion, as previously reported by the facility.The log analysis also confirmed that the infusion was not programmed with a concentration of 0.4 mg/hr with a 0.2 mg bolus.Instead, at 6:52 pm, the device was programmed in pca dose only mode with a pca dose of 0.2 mg, a lockout interval of 5 minutes, and a volume to be infused (vtbi) of 22.2787 ml.The first recorded dose request occurred at 9:12 pm, with a rate of 150 ml/hr and a vtbi of 0.5 ml.The log recorded 38 instances of pca dose request from the 18nov2025 to 19nov2025 with a total volume infused of 11.5 ml.Laboratory testing, as well as external and internal inspection of the suspect devices, could not be performed, as they were not returned for investigation.Proper use of the bd alaris¿ system also requires familiarity with its features, setup procedures, programming steps, iv sets, and accessories.Users should thoroughly read all instructions, including those for any attached modules.The bd alaris¿ pcu serves as the central interface for programming infusions, and the user manual emphasizes the importance of verifying all infusion parameters before pressing the start key to begin therapy.The devices were reported in use for treatment purposes as intended per 21 cfr 820.198(d)(2).Root cause: the root cause of the reported pca programming error was confirmed through event log analysis and is attributed to incorrect programming of the suspect pca module.The infusion was programmed in pca dose only mode rather than as a continuous infusion, contrary to the facility¿s initial report.Additionally, the infusion was not programmed with the expected concentration of 0.4 mg/hr with a 0.2 mg bolus.Instead, the device was programmed in pca dose only mode with a pca dose of 0.2 mg, a 5 minute lockout interval, and a vtbi of 22.2787 ml.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.

• 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: 24159010
• Report Number: 2016493-2026-01709
• Device Sequence Number: 9028810
• Product Code: MEA
• UDI-Device Identifier: 10885403812033
• UDI-Public: (01)10885403812033
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2026

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: 8120
• Device Catalogue Number: 8120 ALARIS PCA MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/11/2026; 02/26/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/13/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2021
• 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-1362-2020
• Patient Sequence Number: 1
• Patient Sex: Unknown