MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2426-0007

Device Problems Insufficient Flow or Under Infusion (2182); Blocked Connection (2888)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 250 ml baxter bag, ndc 0338-0049-02, lot: y290197, exp: may 2020; 50 ml baxter bag, ndc 0338-0049-31, lot: p383174, exp: feb 2020, 0.9% sodium chloride injection; (2) curos caps.The customer¿s report that a bumex infusion had not infused was confirmed.Functional testing was performed.The disposable sets in their ¿as-received¿ state, connected in a secondary setup configuration, exhibited occlusion at the upper smartsite valve and the connection was verified to be fully secured; however reconnecting resolved the issue.The disposable sets passed rate accuracy testing performed through the upper smartsite valve as a secondary infusion after the occlusion was no longer occurring.The cause of the customer¿s experience was a failure of the smartsite valve activating and allowing fluid flow.The root cause of the smartsite failure was not determined.

Event Description

It was reported that a secondary bumex (0.25mg/ml 4mg/250ml) infusion was programmed at 66ml/hr.For 1 hr.The nurse noted that the bag was completely full (not administered), and the safety clamps were unclamped.It was later reported that patient required additional bumex doses which were administered without issue.The customer added that no air in line (ail) alarms were seen in the cqi data, however patient side occlusion alarms were present.Although requested, there was no further information provided.There was no report of patient harm.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 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: 8707398
• MDR Text Key: 148292017
• Report Number: 9616066-2019-01433
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 8015,30873,72213N,8100, TD: (B)(6) 2019
• Patient Outcome(s): Required Intervention