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

Model Number 10014914

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that for a 90 minute irinotecan 25ml infusion, the nurse manually primed the syringe tubing with a normal saline flush syringe, massaged the pressure sensing disc to remove any air, clamped the tubing, and attached the 35ml syringe that had a closed system drug transfer device (cstd) at the end of the syringe; afterward there was a visible column of air in the line extending from the pressure sensing disc to the proximal end of the tubing.The irinotecan is prepared "on-site" and is hand carried down one floor and is at room temperature prior to the infusion.The customer states there was no 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: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8877796
• MDR Text Key: 154017251
• Report Number: 9616066-2019-02258
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403233906
• UDI-Public: 10885403233906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811885
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: 10014914
• Device Catalogue Number: 10014914
• Device Lot Number: 19045222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2019
• 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