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

Model Number 10010453

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Requested patient demographics however customer stated that no patient identification is available.

Event Description

The customer reported that tpn was infusing at an unspecified rate for approximately 4 hours when the user noticed that the tubing separated and leaked above the pump segment.There was no reported patient harm however due to the product failure an infusion of d10 was quickly initiated.

• 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: 8393372
• MDR Text Key: 137928379
• Report Number: 9616066-2019-00489
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021135
• UDI-Public: 7613203021135
• 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: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2021
• Device Model Number: 10010453
• Device Catalogue Number: 10010453
• Device Lot Number: 18096295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2018
• 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
• Patient Outcome(s): Required Intervention