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

Model Number	10010483
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Although requested, additional patient information was not provided.
Event or Problem Description
It was reported that the iv tubing set "snapped" at the connection of the syringe adapter "white piece" and the upper fitment of the tubing, causing an interruption of an epinephrine infusion to the immediate postoperative patient.The clinician clamped the line and restarted the infusion using a new tubing set.There was no consequence or impact to the patient.
Event or Problem Description
It was reported that the iv tubing set "snapped" at the connection of the syringe adapter "white piece" and the upper fitment of the tubing, causing an interruption of an epinephrine infusion to the immediate postoperative patient.The clinician clamped the line and restarted the infusion using a new tubing set.There was no consequence or impact to the patient.
Additional Manufacturer Narrative
The customer¿s report that the iv tubing set "snapped" at the connection of the syringe adapter "white piece" and the upper fitment of the tubing was confirmed.The stress marks and uneven surfaces on the corresponding areas of breakage on the vented spike component indicate an external (lateral) application of force had been applied to the component during use.Functional testing could not be performed due to the set¿s break.The root cause of the breakage was identified as an outside force being applied to the component.The root cause of the outside force could not be identified.

• 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: 10151532
• Report Number: 9616066-2020-01874
• Device Sequence Number: 2101378
• Product Code: FPA
• UDI-Device Identifier: 10885403232602
• UDI-Public: 10885403232602
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K934095
• 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): 05/19/2020

1 Device was Involved in the Event

2 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: 10010483
• Device Catalogue Number: 10010483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Concomitant Medical Products and Therapy/Usage Dates: 8110, 8015, 10010483, SYRINGE, TD (B)(6) 2020