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

Model Number 8120

Device Problems Contamination (1120); Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/29/2022

Event Type  Death  

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 that a patient, who was in the emergency department (ed) receiving hydromorphone 0.4mg/ml at a rate of 0.3 mg/hr and volume to be infused of 25ml via pca pump, was transferred to another facility.The patient transfer reportedly occurred while pca infusion was ongoing.The hospital's pharmacist downloaded the infusion report and noted that they "could not get any data from when the patient was at the receiving facility." once "back" to the original facility, the pharmacist was able to download the infusion data for "the whole time period." there was reportedly "a 50 minute window starting at 1631 of missing infusion data" where pca "alarmed syringe empty." per customer, no other infusion data was available until 1723 while the patient was in high dose therapy mode and a pca max limit alarmed when the maximum 12mg of medication was infused.Subsequently, the patient's oxygen level desaturated in the low 80's.A rapid response was called and narcan 0.2mg was given.The patient reportedly "initially improved but later deteriorated and passed away" two days after the event date.According to the hospital's medication safety officer, it is not believed that the device may have caused or contributed to the death.However, they mentioned that they have "not completely ruled it out until i can inspect the keystroke data against the all infusion data.".

Manufacturer Narrative

Omit : b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.Correction : medical device type.Additional information : device eval by manufacturer?, reason code for no evaluation, if other specify, imdrf annex a, b, c, d, g codes and 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, who was in the emergency department (ed) receiving hydromorphone 0.4mg/ml at a rate of 0.3 mg/hr and volume to be infused of 25ml via pca pump, was transferred to another facility.The patient transfer reportedly occurred while pca infusion was ongoing.The hospital's pharmacist downloaded the infusion report and noted that they "could not get any data from when the patient was at the receiving facility." once "back" to the original facility, the pharmacist was able to download the infusion data for "the whole time period." there was reportedly "a 50 minute window starting at 1631 of missing infusion data" where pca "alarmed syringe empty." per customer, no other infusion data was available until 1723 while the patient was in high dose therapy mode and a pca max limit alarmed when the maximum 12mg of medication was infused.Subsequently, the patient's oxygen level desaturated in the low 80's.A rapid response was called and narcan 0.2mg was given.The patient reportedly "initially improved but later deteriorated and passed away" two days after the event date.According to the hospital's medication safety officer, it is not believed that the device may have caused or contributed to the death.However, they mentioned that they have "not completely ruled it out until i can inspect the keystroke data against the all infusion data.".

• 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: 15119371
• MDR Text Key: 296747192
• Report Number: 2016493-2022-167348
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: (01)10885403812002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043299
• 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: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120 ALARIS PCA MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• 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
• Treatment: 8015
• Patient Outcome(s): Death
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 105 KG