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

Model Number 8100

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2018

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report of the pump modules exhibiting channel disconnected alarms was confirmed.Analysis of the pcu logs showed that at 2:38 pm on (b)(6) 2018 a secondary infusion of magnesium supplement was started on channel a (s/n (b)(4); a channel disconnected/ communication loss event was exhibited at 4:24 pm.At 1:45 pm, channel b (s/n (b)(4) had started to infuse oxytocin 30units/500ml; a channel disconnected/ power loss event occurred at 4:22 pm, inadvertently stopping the infusion.Oxytocin was programmed on channel b again at 4:25 pm; however, a channel disconnected/ power loss event stopped the infusion at 4:27 pm.Visual inspection showed contamination of the male iui connector on channel a.This iui connector had a date code of (b)(6) 2007 making it approximately 11 years old at the time of failure.The pcu male iui connector and channel b female iui connector were in good condition.This matches the customer's description of the facility biomed having replaced worn iui connectors to address the channel disconnect events.Testing replicated the channel disconnect on channel a.The proximate cause of the channel disconnect alarms is contamination of the iui connectors.The root cause of the contamination was not definitely determined.

Event Description

The customer reported an intermittent channel disconnect message on channel b which was infusing oxytocin 30 units/500 ml.The message was displayed more frequently starting at about 16:30.There was also a report of a channel disconnect message on channel a which was infusing a secondary solution of magnesium.After the channel disconnect alarm the medication continued to infuse.The customer replaced an iui connector and the module release latch mechanism.There was no patient harm.

Manufacturer Narrative

The customer¿s report of the pump modules exhibiting channel disconnected alarms was confirmed.Analysis of the pcu logs showed that at 2:38 pm on 29 apr 2018 a secondary infusion of magnesium supplement was started on channel a (s/n (b)(6)); a channel disconnected/ communication loss event was exhibited at 4:24 pm.At 1:45 pm, channel b (s/n (b)(6)) had started to infuse oxytocin 30units/500ml; a channel disconnected/ power loss event occurred at 4:22 pm, inadvertently stopping the infusion.Oxytocin was programmed on channel b again at 4:25 pm; however, a channel disconnected/ power loss event stopped the infusion at 4:27 pm.Visual inspection showed contamination of the male iui connector on channel a.This iui connector had a date code of jun 2007 making it approximately 11 years old at the time of failure.The pcu male iui connector and channel b female iui connector were in good condition.This matches the customer's description of the facility biomed having replaced worn iui connectors to address the channel disconnect events.Testing replicated the channel disconnect on channel a.The proximate cause of the channel disconnect alarms is contamination of the iui connectors.The root cause of the contamination was not definitely determined.

Event Description

The customer reported an intermittent channel disconnect message on channel b which was infusing oxytocin 30 units/500 ml.The message was displayed more frequently starting at about 16:30.There was also a report of a channel disconnect message on channel a which was infusing a secondary solution of magnesium.After the channel disconnect alarm the medication continued to infuse.The customer replaced an iui connector and the module release latch mechanism.There was no patient harm.

• Brand Name: ALARIS® PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 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: 7795412
• MDR Text Key: 117579113
• Report Number: 2016493-2018-00619
• Device Sequence Number: 1
• Product Code: FRN
• 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: Other,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• 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: 06/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2007
• 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
• Treatment: 8015,(2)PRI TUBING,SEC TUBING,8100, TD 04/29/2018
• Patient Sex: Female