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

Model Number 8100

Device Problems Disconnection (1171); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report of channel disconnected alarms was confirmed.Physical inspection showed that the male iui connector of pump module sn (b)(4) had some pins with green deposits and white dried residue.The male iui connector pins for pcu s/n (b)(4) had green deposits, white dried residue and fibers, plus a decrease of plating material.The female iui connector pins for pcu s/n (b)(4) showed signs of white dried residue and large amounts of fibers.Log analysis showed no channel disconnect on the reported event date; however channel disconnect events with communication loss were noted on (b)(6) 2018.Functional testing resulted in the pump immediately failing with a channel disconnected/ power loss event.The root cause of the reported event is attributed to contamination of the iui connectors.

Event Description

The customer reported that during primary infusions of fentanyl 2000mcg/100ml, propofol 1000mg/100ml and levophed either 4mg/250ml or 16mg/250ml, the device alarmed channel disconnected, however, upon evaluation there was no disconnect found.The user obtained a second pcu to infuse the fentanyl and propofol; the new system alarmed channel disconnected also.Again, after evaluation, there was no disconnect found.There was no patient harm.

Event Description

The customer reported that during primary infusions of fentanyl 2000mcg/100ml, propofol 1000mg/100ml and levophed either 4mg/250ml or 16mg/250ml, the device alarmed channel disconnected, however, upon evaluation there was no disconnect found.The user obtained a second pcu to infuse the fentanyl and propofol; the new system alarmed channel disconnected also.Again, after evaluation, there was no disconnect found.There was no patient harm.

Manufacturer Narrative

The customer¿s report of channel disconnected alarms was confirmed.Physical inspection showed that the male iui connector of pump module sn (b)(6) had some pins with green deposits and white dried residue.The male iui connector pins for pcu s/n (b)(6) had green deposits, white dried residue and fibers, plus a decrease of plating material.The female iui connector pins for pcu s/n (b)(6) showed signs of white dried residue and large amounts of fibers.Log analysis showed no channel disconnect on the reported event date; however channel disconnect events with communication loss were noted on (b)(6) 2018.Functional testing resulted in the pump immediately failing with a channel disconnected/ power loss event.The root cause of the reported event is attributed to contamination of the iui connectors.

• Brand Name: ALARIS® PUMP MODULE
• Type of Device: INFUSION PUMP
• 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: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7545824
• MDR Text Key: 109627176
• Report Number: 2016493-2018-00460
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• 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
• Other Device ID Number: 10885403211423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2010
• 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: (5)8100, (6)2420-0500, (2) 8015, TD (B)(6) 2018
• Patient Age: 78 YR
• Patient Weight: 71 KG