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

Model Number 8100

Device Problems Disconnection (1171); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that 4 large volume pumps were infusing on an 8015 unit.Channel c had an unspecified issue.Channel c and d were reconnected and reprogrammed.The nurse then saw that channel a and b stopped infusing and needed to be reprogrammed.Customer reported no patient harm occurred in this event.

Event Description

It was reported from cvicu that 4 large volume pumps were infusing on an 8015 pc unit.Channel c was infusing propofol and had an unspecified issue.Channel c and d were reconnected and reprogrammed.The nurse then saw that channel a and b stopped infusing and needed to be reprogrammed.Customer reported there were no patient adverse effects caused in this event.

Manufacturer Narrative

Additional information: a4, b3, d11, h6 device code.The reported issue that the channels a and b has stopped after infusions had been started on channels c and d was confirmed via log analysis; however the event could not be reproduced during the investigation.The power was recorded to have been interrupted for channels a and b after a basic infusion was started on channel d.The pcu alarmed for ¿channel disconnected¿.The propofol infusion on channel c and the basic channel d infusion remained infusing without interruption during the event.The report that there was an unspecified issue with the channel c propofol infusion could not be confirmed; the system was recorded to have been off for 2 hours and 50 minutes prior to being turned back on and having all four channels started.The inspection and testing process found no existing malfunctions and could not duplicate the incident.It is possible the inherent wiping action at the iui connector pins when attaching and removing a module may have removed the interfering contaminate that caused the channel disconnect event.The system was being used for treatment.A root cause for channels a and b having stopped after infusions had been started on channels c and d could not be identified.Device history review: review of the sn (b)(6) service history record showed the device had a manufacture date of 08/21/2019.A review of the device service history record was performed beginning from the date of manufacture to the present date 08/13/2020 and indicated that this device has not been previously returned for service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10084440
• MDR Text Key: 193948826
• Report Number: 2016493-2020-00833
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• 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: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100, TD (B)(6) 2020.; 8100,(4)PRI TUBING,8015, TD UNK.
• Patient Weight: 100