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

Model Number 8100

Device Problems Imprecision (1307); Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

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 bumex over infused in the cardiology unit.Bumex 12.5mg in 50ml was ordered to run at 4ml/hour continuously as a primary infusion for a patient diagnosed with congestive heart failure (chf).The bag was empty within 30 minutes, and there was no patient harm.During an onsite visit, it was noted that the pcu had a 3rd party front case, and the pump module failed accuracy rate testing.During the testing, a range of 11.64ml to 12.36ml was expected, and the testing read low at 11.53ml.

Manufacturer Narrative

Although requested gender of patient was not provided.The customer¿s report of a bumex over infusion was neither confirmed nor replicated.The pcu event log contained no obvious programming errors that would result in the reported event.Analysis of the pcu event log shows pump module received a remote iv request for drugid 131 to infuse at a rate of 4ml/hr.With a vtbi of 50ml at 2:32 am on 13 may 2019.The infusion ran until 5:38 am when the device was paused.The device was then channeled off at 5:49 am.The volume recorded as being infused during this period was 10.343ml.Functional testing performed found the pump module to be delivering fluid within specification.There were no anomalies observed with the returned primary set (model 2426-0007) and there were no leaks observed from the set.The incident disposable set was evaluated and was found to be within specification.All parts were bd parts.The root cause was not identified.

Event Description

It was reported that bumex over infused in the cardiology unit.Bumex 12.5mg in 50ml was ordered to run at 4ml/hour continuously as a primary infusion for a patient diagnosed with congestive heart failure (chf).The bag was empty within 30 minutes.There was no patient harm.During an onsite visit, it was noted that the pcu had a 3rd party front case, and the pump module failed accuracy rate testing.During the testing, a range of 11.64ml-12.36ml was expected, and the testing read low at 11.53ml.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8734736
• MDR Text Key: 149212170
• Report Number: 2016493-2019-00717
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (y/n): N
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• 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: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2426-0007,100ML EVA CONTAINER; PRI TUBING,8015, THERAPY DATE (B)(6) 2019; PRI TUBING,8015, THERAPY DATE (B)(6) 2019
• Patient Age: 61 YR
• Patient Weight: 130