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

Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945)

Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

Per medsun report "levophed and amiodarone drips inside iv channels; once channel opened iv tubing's blue safety clamp did not engage and left medicine to free flow if roller clamp was not engaged." add'l info received from the customer: customer reported that the both channels "free-flowed".Customer stated that both devices were evaluated by biomed, passed preventative maintenance and were placed back into service.The iv sets were discarded and no event logs were available.There was no report of pt harm or medical intervention.No add'l pt or event details were provided by the customer.

Manufacturer Narrative

This report was filed by the mfr.Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION CORP; san diego CA
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121 ; 8586176477
• MDR Report Key: 4290111
• MDR Text Key: 5059034
• Report Number: 9616066-2014-01116
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ALARIS PC UNIT AND PUMP MODULE
• Patient Age: 69 YR
• Patient Weight: 98