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

Model Number	8100
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); No Audible Prompt/Feedback (2282)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Respiratory Failure (2484)
Date of Event	03/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the evaluation is completed.Diagnosis- acute respiratory failure with hypoxemia.Evaluation pending.
Event or Problem Description
It was reported that after several hours of a norepinephrine infusion being run, the bag remained full.The rate was 63 ml/hour with a 250 ml bag, therefore the bag should have required replacement every 4 hours.Upon investigation, the tubing inside the channel was sealed together in two areas obstructing flow.During administration the pump was not alarming for occlusion, or empty container.Patient required administration of additional, new drug, vasopressin, for blood pressure support and to stabilize patient's blood pressure, while the tubing was not functioning correctly.The patient remained in icu, ultimately no effect once error was detected.As stated by customer.No further information is available.
Event or Problem Description
It was reported that after several hours of a norepinephrine infusion being run, the bag remained full.The rate was 63 ml/hour with a 250 ml bag, therefore the bag should have required replacement every 4 hours.Upon investigation, the tubing inside the channel was sealed together in two areas obstructing flow.During administration the pump was not alarming for occlusion, or empty container.Patient required administration of additional, new drug, vasopressin, for blood pressure support and to stabilize patient's blood pressure, while the tubing was not functioning correctly.The patient remained in icu, ultimately no effect once error was detected.As stated by customer.No further information is available.
Additional Manufacturer Narrative
The complaint of an under infusion was not reproduced.The complaint of failure to alarm occlusion was also not reproduced.Inspection lvp sn (b)(6).The device was received in fair condition.The instrument seal was peeled up.Dried fluid was observed on the male iui, on the rear case under the female iui, and inside the rear case dried fluid and corrosion were observed on the female iui.Damage observed on the lighthouse.Crush marks observed at the upper fitment of the tube guide which is indicative of a set misload.Platen assembly, post, hinge, pins, springs, and buttons are all intact and did not interfere with the door operation.Latch sear are installed properly and did not interfere with the door operation.All parts inspected are manufactured by bd.Iui bracket was observed with a broken plastic tab; the broken piece was not recovered during disassembly bezel was disassembled and observed in fair condition.The event administration set was not returned for investigation.However, the provided picture showed the set was partially fused at two locations.This could be a contributing factor, however since it was not returned it could not be tested.Review of the pcu error log showed no errors were recorded on the reported event date.Review of the pcu event log showed the suspect device successfully completed multiple infusions of guardrail drug norepinephrine (8mg/250 ml; drugid=473) at multiple rates.No alarms were recorded.Volume infused= 811.49 ml.Inspection of the device showed the pressure sensors were in good condition.Testing showed the pressure sensors performed within specification.Testing showed the device was delivering fluids within specification.Root cause analysis: the root cause of the complaint of an under infusion was not identified.The root cause of the complaint of failure to alarm occlusion was not identified.Device history review: lvp sn (b)(6).A review of the device history record showed the device had a manufacture date of 04/14/2015.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 source device lvp sn (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 source device lvp sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

• Brand Name: ALARIS PUMP MODULE
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11689294
• Report Number: 2016493-2021-502709
• Device Sequence Number: 3401508
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (Y/N): N
• PMA/510(K) Number: K133532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015; 8100; 8100; 8100; PRI TUBING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 69