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

Model Number	10013186
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during an infusion the pump alarmed; air-in-line.In an attempt to "flick" the tubing to move the air, the tubing set broke at the pumping segment.
Event or Problem Description
It was reported that during an infusion the pump alarmed; air-in-line.In an attempt to "flick" the tubing to move the air, the tubing set broke at the pumping segment.
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint of pump alarmed air-in-line.In an attempt to "flick" the tubing to move the air, the tubing set broke at the pumping segment could not be confirmed.Although the attached photo does not represent the actual event sample for this event, it identifies the described separation location (silicone to lower fitment).However, the photo does not confirm a set broke ¿separation¿.The root cause of this failure was not identified as no product was returned.

• 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: 9101790
• Report Number: 9616066-2019-02638
• Device Sequence Number: 2782491
• Product Code: FPA
• UDI-Device Identifier: 07613203021173
• UDI-Public: 7613203021173
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: 10013186
• Device Catalogue Number: 10013186
• 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: 09/22/2019
• Supplement Report FDA Received Date: 11/18/2019
• 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, TD UNK