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

Model Number	10178573
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: quality systems specialist iii.No product will be returned per customer.No investigation was performed.
Event or Problem Description
It was reported that the er patient was initiated on ketamine 8.5mg/100ml ns for pain management in the ct room.During the ct scan the tubing leaked at the silicone segment of the tubing and sprayed the window and the floor.The amount of medication given was uncertain as the entire contents of the bag was lost and the pump was immediately turned off.The pharmacist examined the bag and line and noted that the iv line just below the spike where the line was attached to the bag had completely 'burst' and was about 25% attached to the spike and the bag.The patient continued to have escalating pain so a second dose was prepared, however the pain escalated further and additional intervention was required.The customer stated the devices will be investigated by a third party company and will not be returned.There was no lasting harm.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8607804
• Report Number: 9616066-2019-01286
• Device Sequence Number: 2042488
• Product Code: FPA
• UDI-Device Identifier: 07613203021111
• UDI-Public: 7613203021111
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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
• Operator of Device: Health Professional
• Device Model Number: 10178573
• Device Catalogue Number: 10178573
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100, 8015, PRI TUBING, THERAPY DATE (B)(6) 2019
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 83