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

Model Number 8110

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

No product returned.Because no device or device logs were returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.No devices received, log review only.

Event Description

It was reported that an infusion of alprostadil (pge) was programmed on a syringe pump to run for 30 hours, but completed within 9 hours.The intended programming was as follows alprostadil 25mcg in 2.5 ml (10mcg/ml) to run at 0.06 ml/hr continuously.Although requested, no further information regarding patient involvement and outcome was provided.Patient harm is unknown.

Event Description

It was reported that at the start of the shift (2300) the rn double checked all medications/infusions with off-going nurse, including the alprostadil (pge), which had been hung prior to my arrival @ 2300 by offgoing rn.All infusions were found to be running at the appropriate concentration and dose per setup.Around 0600 the syringe pump was reading "syringe empty" on the pge despite the brain pump reflecting that there should be almost 45 minutes left in the syringe by volume.The nurse happened to have had this patient the previous night shift and she questioned why the pge syringe could be empty already if a new one was hung overnight, as in her experience this syringe should last for >12 hours (31 hours is the runtime based on 2.5mls syringe that had tubing primed with separate syringe).It was determined that the patient got approx.31 hours¿ worth of medication at prescribed dose over about 9 hours.No patient harm was reported.

Manufacturer Narrative

Time of the event: 0600 on (b)(6) 2021.Patient information: pediatric.Investigation conclusion: the report of a device infusing faster than expected was not definitively confirmed.The pcu event log shows syringe module s/n (b)(6) was programmed to infuse drugid 13 at 7:14 pm on (b)(6) 2021.The event description stated the infusion was to last for 30 hours, however the log shows that the syringes selected did not have enough detected volume to last that long.Different syringes with varying detected volumes were selected during the infusion and the cause of the variance was not determined.The syringe module detects syringe sizes via the syringe clamp that assesses the syringe¿s outer diameter and compares it to syringe profiles/configurations in memory and can automatically identify the size of an approved syringe once the user confirms the brand of syringe and size being used.Once the syringe is loaded, the syringe module is designed to detect the amount of fluid in the loaded syringe.Alaris system maintenance software was used to test the returned syringe module for functionality (barrel clamp accuracy, plunger position accuracy and plunger force accuracy).The returned syringe module passed all tests.Device inspection: syringe module s/n (b)(6) was received with instrument seal intact.The right (male) iui was observed with damaged isolation ribs and dry fluid residue.The left (female) iui was observed to be in good condition.Drive head up/down vertical movement was observed to move freely after opening the gripper control.The gripper control opened and returned to close position as intended.Barrel clamp assembly was functioning as intended.All parts inspected are manufactured by bd.The incident administration set was not returned and could not be inspected.Root cause analysis: the root cause of the reported device infusing faster than expected was not identified in this investigation.Device history review: a review of the device history record showed the device had a manufacture date of 20jun2011.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for syringe module s/n (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the syringe module s/n (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.Device received for evaluation.

• Brand Name: ALARIS SYRINGE PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11330381
• MDR Text Key: 231997834
• Report Number: 2016493-2021-25341
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403424267
• UDI-Public: 10885403424267
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8110
• Device Catalogue Number: 8110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8110,(2)SYR TUBE , TD (B)(6) 2021