MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD-LEGACY PCA AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

Model Number	6300
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cadd oxycodone was in constant purge.Per reporter, the pump was clamped immediately.The patient was asleep and not responsive to stimulation.Naloxone was administered to the patient with oxygen and the patient woke up after intervention.Review of the device programming showed no abnormality.The patient received 39.2 ml in a very short period of time.The oxycodone concentration was 1mg/1ml/hour with a continuous flow rate of 20 hours to 8 hours at 0.2 ml/hour and bolus of 0.2ml/20 minutes.Per reporter, the patient was checked by the nurse prior to the event, and the patient was awake with normal consciousness and normal parameters.Per reporter, the patient was receiving pain relief prior to this event.When the history of doses was reset to zero in order to see the use made by the patient, the nurse reviewed the history showed 2 bolus attempts but that the patient received zero.Reporter stated that in view of the patient¿s areactivity (rudkin 5), a measurement of parameters and a capillary blood sugar test is done to the patient, and the nurse was challenged by the purge noise of cadd while it was in constant purge.
Additional Manufacturer Narrative
H3: one pump was returned for analysis in used condition.The customer stated the pump was in priming for 30 minutes, delivering 39.2 ml of oxycodone prepared with a concentration of 1mg/1ml over a very short time, overdosing the patient, who later required medical intervention (naloxone).The customer reported of patient overdose was able to be confirmed through event history inspection, but the "constant purge" was unable to be confirmed or duplicated during repair activities.Functional testing showed the device was infusing properly.The cause of the reported issue was an error in user programing (50,00 mg/hour delivery rate instead of 0,00 mg/hour mentioned in the report).Preventative maintenance was performed before returning the device to the customer.

• Brand Name: CADD-LEGACY PCA AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22205785
• Report Number: 3012307300-2025-07069
• Device Sequence Number: 6755403
• Product Code: MEA
• UDI-Device Identifier: 10610586019357
• UDI-Public: (01)10610586019357(11)170323
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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 Model Number: 6300
• Device Catalogue Number: 21-6300-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2017
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NALOXONE; OXYCODONE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown