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

Model Number 8100

Device Problems Disconnection (1171); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 8015; 8110; pri tubing; spm tubing; bd syringe 5ml and bd syringe 3ml; therapy date (b)(6) 2018.The customer¿s report of a communication error was confirmed.Analysis of the pcu logs showed the pcu powered on at 5:23 am on (b)(6) 2018 with pump module s/n (b)(4) (channel a) and syringe module s/n (b)(4) (channel b) attached.The system was identified with the profile ¿nicu¿ in use on this day.On this day, at 5:23 am, source pump module was programmed with dextrose 10% (drugid 40) at a rate of 5.9ml/h and vtbi of 5.9ml.Volume infused was recorded at 0.0ml.Syringe module was programmed with two different infusions starting at 5:51 am; volume infused was recorded at 0.0ml.The initial infusion infused at 8ml/h; once empty, a second infusion at the same rate was initiated.The second infusion completed at 6:20:33 am when the syringe was empty; seconds later the module was channeled off.The total volume infused was recorded at 3.6415ml.At 6:25 am, the pump module infusion completed (kvo).The infusion was restored twice the following 10 minutes after completing (kvo) each infusion.At 8:27 am, the system alarms for a ¿channels disconnected¿ error event, due to a communication loss with the pcu.Total volume infused was recorded at 17.834ml.At 10:02 am, syringe module was channeled off; seconds later the system powers off.Inspection of the source device iui connector components, with the use of magnification, observed contamination on channel a pump module (male iui connector) and pcu (female iui connector).The proximate cause of the reported communication error is the presence of contamination in the iui connectors.The root cause of the contamination on the iui connector pins was not definitely determined.

Event Description

The customer reported while infusing on a patient, a communication error occurred.The customer did not note any iui damage, corrosion, or film.There was no patient harm.

• Brand Name: ALARIS® PUMP MODULE
• 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7920376
• MDR Text Key: 122469997
• Report Number: 2016493-2018-00727
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• 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: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2009
• 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