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

Model Number ALARIS® SYSTEM PC UNIT - 8015

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Swelling (2091)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

Report suggests the nurse found mild swelling around the iv site.Device did not demonstrate any issues.

Manufacturer Narrative

The report of an occlusion - no alarm (infiltration) was not confirmed.Review of the pump module¿s event log for (b)(6) 2019 13:53 to 14:40 identified that the air-in-line alarm was set to 75ul, the occlusion alarm was set to 450mmhg and the occlusion restart attempts was set to 1.Analysis of the pcu event log identified the following sequence of events having occurred on (b)(6) 2019: at 13:53 pcu powered on with pump module (b)(6) attached.At 13:54 basic infusion started at 150.0ml/h with a vtbi of 48.0ml (vi = 0.0ml).At 14:13 a vtbi of 48.0ml was entered (vi = 47.004ml).At 14:32 pump alarmed vtbi completed and kvo started (vi = 95.025ml).At 14:35 an infusion was started at 700.0ml/h with a vtbi of 480.0ml (95.029ml).At 14:40 pump performed an auto restart.At 14:40 pump alarmed partial patient side occlusion (vi = 155.75ml).At 14:40 channel off.At 14:40:39 pcu powered off part of the alaris system¿s downstream occlusion detection system is designed to minimize nuisance, patient-side occlusion alarms.It allows the system to automatically continue an infusion following detection of a patient-side occlusion if downstream pressure falls to an unacceptable level within a 15 second ¿checking line¿ period.If this feature is enabled, ¿checking line¿ function occurs when downstream pressure exceeds pressure limit.In selectable pressure mode: pressure limit is either user-adjustable or ¿locked¿ in system configuration.In pump pressure mode: pressure limit is a function of flow rate and is automatically determined by device.If downstream pressure decreases to a predetermined level, (below 50% of pressure limit) during 15 second ¿checking line¿ period, the infusion automatically continues.If the condition is not cleared within 15 seconds, a ¿partial occlusion ¿ patient-side¿ alarm occurs.Using editor software, the system can be configured to allow 0 (zero) to 9 restart attempts within a rolling 10 minute period.If allowable number of restarts is exceeded or if the feature is set to zero, an ¿occluded ¿ patient-side¿ alarm occurs when the system detects downstream pressure that exceeds pressure limit.The root cause of the reported no alarm was not identified.Pump is neither designed nor intended to detect infiltrations and does not alarm under infiltration conditions.Device history review: the device history record was reviewed at the manufacturing facility, and it did not show any manufacturing issues during production build for the pcu or pump module.H3 other text : no devices received, log review only.

Event Description

Report suggests the nurse found mild swelling around the iv site.

• Brand Name: ALARIS SYSTEM PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9597106
• MDR Text Key: 177592562
• Report Number: 2016493-2020-00086
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALARIS® SYSTEM PC UNIT - 8015
• Device Catalogue Number: ALARIS® SYSTEM PC UNIT - 8015
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100, THERAPY DATE 12/20/2019