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

Model Number 8015

Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Inadequate User Interface (2958)

Patient Problems Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Although requested, the affected device has not been received.A follow up report will be submitted with investigation results should the device be received for evaluation.Although requested, no additional patient information provided.

Event Description

It was reported that there was a programming error that resulted in an adverse patient event.There were 2 lvps attached at the pcu at the time of the event.Channel "a" was infusing syntocinon and channel "b" was infusing normal saline.Per the reporter, the event was an "operator error." normal saline was programmed at the ordered syntocinon rate and syntocinon programmed at the ordered normal saline rate.There was no additional information provided at this time.

Event Description

It was reported that there was a programming error that resulted in an adverse patient event.There were 2 lvps attached to the pcu at the time of the incident.Channel "a" (s/n: (b)(6) was infusing syntocinon (30 units in 500ml ns) and channel "b" (s/n: (b)(6) was infusing 0.9% normal saline.Per the reporter, the event was an "operator error." normal saline was programmed at the ordered syntocinon rate and syntocinon programmed at the ordered normal saline rate.The specific rates of each drug were not provided.As a result of the event, the obstetric team was called and the patient was prepared for an emergency caesarean (cat 1 lscs.) although requested, there was no additional event or patient information provided.

Manufacturer Narrative

The customer¿s stated issue of programming error was confirmed through a review of the device logs.The customer¿s stated issue of programming error was confirmed through a review of the device logs.Inspection: pcu sn: (b)(6).The suspect pcu was received in good condition with the instrument seal broken.The front cover and rear case are in good condition.The male and female iui¿s have dried fluid on the contact pins.The handle and battery appear to be in good condition.All parts inspected were determined to be manufactured by bd.Log analysis results: results from a review of the pcu error log shows no malfunctions on the reported event date and time.The log review confirmed a programming error that would explain the report of programming error.Channel a, sn: (b)(6) was received with a customer label attached that read: a, syntocinon infusion 30u/s in 500ml saline.However, the pump module was programmed to infuse at a rate of 167 ml/h and was then increased to 500ml/h.A total calculated volume of 68.187 ml was infused on channel a.Channel b, sn: (b)(6) was received with a customer label attached that read: b, hartmanns 100ml.This channel was programmed to infuse drug id 103 (oxytocin) at a rate of 1 ml/h.The reported drug ¿syntocinon¿ in use is listed as drug ¿oxytocin¿ in the customers dataset.A total calculated volume of 0.16 ml was infused on channel b.Functional testing consisting of rate accuracy testing performed on both source pump modules found the devices operating in specification.The root cause of the customer¿s complaint was identified due to programming.Device history review: a review of the complaint history record in trackwise and sap was performed for the sn: (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.A review of the device history record showed the device had a manufacture date of 05/22/2020.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for sn: (b)(6) was performed which confirmed that this device was involved in a production failure which did not correlate to the customer reported issue.

Event Description

It was reported that there was a programming error that resulted in an adverse patient event.There were 2 lvps attached to the pcu at the time of the incident.Channel "a" (s/n (b)(6)) was infusing syntocinon (30 units in 500ml ns) and channel "b" (s/n (b)(6)) was infusing 0.9% normal saline.Per the reporter, the event was an "operator error." normal saline was programmed at the ordered syntocinon rate and syntocinon programmed at the ordered normal saline rate.The specific rates of each drug were not provided.As a result of the event, the obstetric team was called and the patient was prepared for an emergency caesarean (cat 1 lscs.) although requested, there was no additional event or patient information provided.

• Brand Name: ALARIS PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11159440
• MDR Text Key: 226567655
• Report Number: 2016493-2021-02380
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2) PRI TUBING.; (2) PRI TUBING
• Patient Outcome(s): Required Intervention