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

Model Number 2426-0007

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 72213n; 50ml pfizer bag ndc 0206-8861-01, lot ln109871, exp 15sep18, piperacillin-tazobactam; td (b)(6) 2018.The customer¿s report of an air-in-line alarm prior to the completion of an infusion, and the iv bag was empty although the pump indicated remaining medication, was not confirmed.Visual inspection of the set did not reveal any discernible damage or abnormalities.Functional testing resulted in no abnormalities in fluid flow or formation of air pockets.The root cause of the failure was not determined.

Event Description

The customer reported that zosyn 3.375 grams in a 50 ml bag was to infuse over 4 hours at 12.5/hr.The zosyn was started at 2043 then at approximately 2330 the pump alarmed due to air in line with approximately 6 inches of visible air.Zosyn was restarted and the pump displayed 30 ml left in the bag although the bag appeared to be empty.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: 7451471
• MDR Text Key: 106403710
• Report Number: 9616066-2018-00522
• Device Sequence Number: 1
• Product Code: FPA
• 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: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Other Device ID Number: 10885403227998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Date Manufacturer Received: 04/04/2018
• 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