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

Model Number 8015

Device Problems Use of Device Problem (1670); Inaccurate Delivery (2339)

Patient Problem Hypoxia (1918)

Event Date 08/05/2022

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.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 a patient incident occurred where "the morphine pca concentration order was changed from 1 mg/ml to 5 mg/ml." however, the dose/rate was "not changed on the pump until hours later, even though the syringe had been changed to the new concentration.The nurse had a hard time figuring out how to reprogram.They thought the patient was receiving the correct dose, but in fact that the concentration was incorrect, so the pump was delivering the wrong doses." the customer added that "as part of the solution we are trying to make our pca library nomenclature clearer," pertaining to the guardrails drug library that hospitals can customize.The customer stated that at the time of the event, the patient was in palliative care with neurofibromatosis type 1 and recurrent high-grade glioma that was admitted with acute on chronic respiratory failure.The pca infusion was switched from a morphine "1mg/1ml" concentration to a "5mg/ml" concentration on (b)(6) 2022 at 1408.The patient reportedly received the incorrect dose from (b)(6) 2022 at 1408 to (b)(6) 2022 at 0149.Per provider's assessment, the patient's respiratory rate and oxygen saturation levels had been trending down.The patient had been receiving oxygen during this time and no additional interventions occurred.It was then reported that the patient passed away on (b)(6) 2022 at 1701.The customer (pharmd medication safety officer) stated that "at this time, the pca medication error is not thought to have contributed to the patient's death.".

Manufacturer Narrative

Omit: b17 - device not returned, c20 - no findings available, d15 - cause not established.Additional information : device available for eval?, returned to manufacturer on, device return to manuf.?, device eval by manufacturer?, if other specify, imdrf annex a, g, b, c, d codes & manufacturer narrative.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.H3 other text : not applicable.Device evaluated by bd.

Event Description

It was reported that a patient incident occurred where "the morphine pca concentration order was changed from 1 mg/ml to 5 mg/ml." however, the dose/rate was "not changed on the pump until hours later, even though the syringe had been changed to the new concentration.The nurse had a hard time figuring out how to reprogram.They thought the patient was receiving the correct dose, but in fact that the concentration was incorrect, so the pump was delivering the wrong doses." the customer added that "as part of the solution we are trying to make our pca library nomenclature clearer," pertaining to the guardrails drug library that hospitals can customize.The customer stated that at the time of the event, the patient was in palliative care with neurofibromatosis type 1 and recurrent high-grade glioma that was admitted with acute on chronic respiratory failure.The pca infusion was switched from a morphine "1mg/1ml" concentration to a "5mg/ml" concentration on (b)(6) 2022 at 1408.The patient reportedly received the incorrect dose from (b)(6) 2022 at 1408 to (b)(6) 2022 at 0149.Per provider's assessment, the patient's respiratory rate and oxygen saturation levels had been trending down.The patient had been receiving oxygen during this time and no additional interventions occurred.It was then reported that the patient passed away on (b)(6) 2022 at 1701.The customer (pharmd medication safety officer) stated that "at this time, the pca medication error is not thought to have contributed to the patient's death.".

• 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: 15367734
• MDR Text Key: 299351719
• Report Number: 2016493-2022-187634
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801549
• UDI-Public: (01)10885403801549
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 8015
• Device Catalogue Number: 8015 ALARIS PCU 1.5 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 08/13/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2019
• 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: 8 YR
• Patient Sex: Male
• Patient Weight: 42 KG