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

Model Number 8015

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer¿s report of an error code 255-16-275 event was confirmed.Review of the logs confirmed the error, recorded as error code 800.8000.0, exhibited on (b)(6) 2018 at 01:58 am.The pcu was turned on prior to the day of the incident at 9:15 am on (b)(6) 2018, with the profile heart center in use.Four pump modules were attached.At 01:33 am on (b)(6) 2018, while channel b was being programmed with an infusion, a flow stop open alarm was recorded.A second later, the ¿start¿ soft key 14 was pressed to begin the infusion.At 1:58 am, a vtbi of 240mls was added to the infusion and the pump was restarted resulting in an error 800.8000 system error.The system was powered on again at 08:58 am on (b)(6) 2018.The user¿s programming key presses were replicated, subsequently producing a system error 255-16-275 condition, logged as a 800.8000 (general os failure) in the error log as previously identified in the customer¿s logs.During this error state, the pump module will continue to infuse while displaying a communication error.The root cause of the error code is a software anomaly; involving the user selecting two functions at the same time or in rapid succession.In this case, the door was closed after a ¿safety clamp open/close door¿ alarm and in rapid succession, the start button was pressed after restoring an infusion.The next change in state (restart) then triggered the error.

Event Description

The customer reported that the nurse observed the pcu display screen turn red with error code 255-16-275; it was unknown if there were battery discharge alarms.There was no report of patient harm.The event occurred in pccu.Although requested, no additional information about the patient, medication, or event was provided.The biomed reported that bd batteries are used, and during every preventive maintenance the battery is manually conditioned every 12 months by qualified service personnel.The battery is replaced every 2 years.The battery maintenance record would reflect if the unit was sent for reconditioning and there is no record.The new battery would have a date placed on it with a permanent marker.The tech at the time did the marking along with a sticker on the front of the case to identify which units had been completed.

• Brand Name: ALARIS PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8207258
• MDR Text Key: 131774220
• Report Number: 2016493-2018-01001
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• 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: 10/11/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1