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

Model Number 8100

Device Problems Material Fragmentation (1261); Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

Patient diagnosis- prematurity.Although requested, ethnicity, race not provided.The affected device has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

It was reported that an overinfusion of total parenteral nutrition (tpn) occurred.The tpn was verified appropriately with a normal amount of overfill and the nurse who hung it said there was no waste upon starting it.It appears the rate was ok all night too.The infusion was hung as the primary and the rate was set at 4.1ml/hour, beginning at 1818 on (b)(6) then was changed to 4.0 ml/hour at 1159 on (b)(6).The tpn bag ran dry around 9 am when it should have lasted until the evening.This event caused an interruption of the intended therapy so the patient had to be transitioned to a starter tpn.The clinician noted there was extra entry into the iv tubing due to this change in therapy, which increases the risk of infection to the patient.The pharmacy noted there were no programming errors or unusual alarms on the report.Lvp and syringe module are owned by agiliti and are overdue for maintenance.Pcu is owned by nch.Drug library and pm are up-to-date; pm done by ohiohealth biomed (07/2020).No error codes found on devices on device for 3-2 thru 3-3.Lvp module failed the patient side occlusion, occluded @ 4.4psi.Recalibrated and now occludes @ 8.4psi.Ran device through 2 rate accuracy tests.Both passed ams tests.Could not duplicate issue of over infusion.Although requested, further information not provided.

Manufacturer Narrative

The customers reported issue of over infusion of tpn was not confirmed or replicated.Laboratory testing did confirm a slight over-infusion of about 1%, but this would not account for the customers experience.The customer also stated the device was tested on site and passed asm rate accuracy twice.Inspection: the pump module was received with instrument seal missing.The right (male) iui was observed with corrosion, damaged isolation ribs, and dry fluid residue.The left (female) iui was observed dull.The sear assembly was observed to be broken.Internal inspection observed no anomalies with any of the electrical or mechanical components.Review of the returned devices logs observed no errors or malfunctions on any of the returned devices on the customers reported incident date.The pump module log did not record any air in line alarms.On (b)(6) 2021 at 6:17 pm the pump module alarmed for door open, flow stop open (4 seconds) and the door was closed.The pump module was selected for programming the rate was changed to 4.1ml/h, a vtbi of 4.1ml was entered and the infusion was started.Pvi at the time 94.61ml.The user added vtbi throughout the duration of the infusion and there were 4 observed completed infusions (8:37 pm, 11:53 pm, (b)(6) 2021 at 3:12 am and 9:25 am) each time the user added vtbi and restarted the infusion.The device was channeled off on (b)(6) 2021 at 11:54 am.Pvi at the time 166.71ml.Keypress replication observed the source device delivering fluid as programmed and time rate accuracy observed the device delivering fluid within specification after the device was successfully calibrated.Additional testing observed pump module with the noted broken sear failed to engage the safety clamp during the first use when using a new set (2200-0500) when opening the door using a rapid motion.Inspection of the device observed a broken sear assembly, no other anomalies were observed that would contribute to the customers reported complaint.Root cause: the root cause of the customers reported over infusion of tpn was not replicated during testing of the returned device or observed in the device¿s event logs.However, a broken sear assembly was observed and previous investigations have shown that a broken sear may not fully engage the safety clamp when the pump module door is opened, resulting in unintended free flow.Device history review: a review of the device history record showed the device had a manufacture date of 06/06/2006.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 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 in trackwise and sap was performed for the s/n (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

Received a copy of the customer's medwatch (b)(4) report from fda which states, ¿notes from nurse: total parenteral nutrition (tpn) infusing bag ran dry in the morning when it should have lasted until the evening.The tpn was verified appropriately with a normal amount of overfill and the nurse who hung it said there was no waste upon starting it.It appears the rate was ok all night too.Notes from pharmacy: no programming errors or unusual alarms on the report." it was reported that an over infusion of total parenteral nutrition (tpn) occurred.The tpn was verified appropriately with a normal amount of overfill and the nurse who hung it said there was no waste upon starting it.It appears the rate was ok all night too.The infusion was hung as the primary and the rate was set at 4.1ml/hour, beginning at 1818 on (b)(6) 2020 then was changed to 4.0 ml/hour at 1159 on (b)(6) 2020.The tpn bag ran dry around 9 am when it should have lasted until the evening.This event caused an interruption of the intended therapy so the patient had to be transitioned to a starter tpn.The clinician noted there was extra entry into the iv tubing due to this change in therapy, which increases the risk of infection to the patient.The pharmacy noted there were no programming errors or unusual alarms on the report.Lvp and syringe module are owned by agiliti and are overdue for maintenance.Pcu is owned by (b)(6).Drug library and pm are up-to-date; pm done by (b)(6) (07/2020).No error codes found on devices on device for 3-2 thru 3-3.Lvp module failed the patient side occlusion, occluded @ 4.4psi.Recalibrated and now occludes @ 8.4psi.Ran device through 2 rate accuracy tests.Both passed ams tests.Could not duplicate issue of over infusion.Although requested, further information was not provided.

Event Description

Received a copy of the customer's medwatch 3633050000-2021-8013 report from fda which states, ¿notes from nurse: total parenteral nutrition (tpn) infusing bag ran dry in the morning when it should have lasted until the evening.The tpn was verified appropriately with a normal amount of overfill and the nurse who hung it said there was no waste upon starting it.It appears the rate was ok all night too.Notes from pharmacy: no programming errors or unusual alarms on the report." it was reported that an overinfusion of total parenteral nutrition (tpn) occurred in the neonatal intensive care unit (nicu) during use on an premature infant.The tpn was verified appropriately with a normal amount of overfill and the nurse who hung it said there was no waste upon starting it.It appears the rate was ok all night too.The infusion was hung as the primary and the rate was set at 4.1ml/hour, beginning at 1818 on 3/1 then was changed to 4.0 ml/hour at 1159 on 3/2.The tpn bag ran dry around 9 am when it should have lasted until the evening.This event caused an interruption of the intended therapy so the patient had to be transitioned to a starter tpn.The clinician noted there was extra entry into the iv tubing due to this change in therapy, which increases the risk of infection to the patient.The pharmacy noted there were no programming errors or unusual alarms on the report.Lvp and syringe module are owned by agiliti and are overdue for maintenance.Pcu is owned by nch.Drug library and pm are up-to-date; pm done by ohiohealth biomed (07/2020).No error codes found on devices on device for 3-2 thru 3-3.Lvp module failed the patient side occlusion, occluded @ 4.4psi.Recalibrated and now occludes @ 8.4psi.Ran device through 2 rate accuracy tests.Both passed ams tests.Could not duplicate issue of over infusion.Although requested, further information not provided.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11769328
• MDR Text Key: 262902161
• Report Number: 2016493-2021-503803
• Device Sequence Number: 1
• Product Code: FRN
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

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: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 04/30/2021; 04/30/2021
• Supplement Dates FDA Received: 05/26/2021; 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015; 8110; PRI TUBING; SYR TUBING; SYRINGE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 1 MO
• Patient Weight: 1