MAUDE Adverse Event Report: CAREFUSION SD 8120 ALARIS PCA; PUMP, INFUSION

Model Number 8120

Device Problems Computer Software Problem (1112); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s experience of an incorrect syringe volume read was not confirmed.The pcu event log shows pca s/n (b)(4) was programmed to infuse a pca dose + continuous infusion of hydromorphone standard dose 10mg in 50ml (drugid 270) using a 60ml monoject syringe with 48.6575ml detected at 12:58 pm on (b)(6) 2018.The infusion ran until 11:16 pm when the infusion completed due to the syringe becoming empty.There were 23 pca dose requests delivered and 4 pca dose requests not delivered (due to the lockout interval) during this period with a recorded volume infused of 48.6575ml.At 11:24 pm, the user selected a 50/60ml bd plastipak syringe.Between 11:24 pm and 11:45 pm, the user attempted to program an infusion of hydromorphone several times, but does not cancel the programming and channels the device off, shutting down and powering off the system.The volume in the syringe is not displayed until the user is at the rate entry screen, which the user never got to after selecting the 50/60ml bd plastipak syringe.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was not returned for servicing which not correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.

Event Description

The customer reported that when replacing an empty dilaudid syringe on the pca, the patient and correct dose for the patient was verified, but when placing the syringe the pca did not show the correct dose and concentration.A second nurse confirmed this when verifying the prescribed dose and concentration.To double check the pca error, a new pca was placed and staff was able to correctly program with correct syringe size and concentration.Although requested, no further information has been received.

• Brand Name: 8120 ALARIS PCA
• Type of Device: 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: hariharan manikandan ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10964764
• MDR Text Key: 230022861
• Report Number: 2016493-2020-59798
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: 10885403812002
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• 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