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 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 from cvicu 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 there were no patient adverse effects caused 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

Correction: disregard file (after further review, the device 8100 lvp s/n (b)(6) is not a suspect).

• 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: 10084441
• MDR Text Key: 193626518
• Report Number: 2016493-2020-01145
• 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,(4)PRI TUBING,8015, TD UNK