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

Model Number	10813621
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information requested but not provided.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that the alaris infusion tubing spontaneously separated while medication was being infused.The separation was picked up when the pump kept alarming air in line.No entrained air reached the patient.
Event or Problem Description
It was reported that the alaris infusion tubing spontaneously separated while medication was being infused.The separation was picked up when the pump kept alarming air in line.No entrained air reached the patient.There has been no further impact to patient response or additional event information made available to date.
Additional Manufacturer Narrative
Additional information added; h.6.(patient code).No product will be returned per customer.The customer complaint of tubing separated was confirmed.A photo provided by the customer shows that the silicone tubing was torn away from the upper fitment.The root cause of the tear could not be definitively determined.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9630496
• Report Number: 9616066-2020-00268
• Device Sequence Number: 1709208
• Product Code: FPA
• UDI-Device Identifier: 10885403234514
• UDI-Public: 10885403234514
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: 10813621
• Device Catalogue Number: 10813621
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2020
• Supplement Report FDA Received Date: 03/02/2020
• 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, TD (B)(6) 2020.