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

Model Number	72215N
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
It was reported that there were secondary tubing sets that separated at the drip chamber in the emergency department.It was a total of four secondary tubing sets involved, all occurring before patient use.One set separated upon priming of an antibiotic, one occurred while "uncoiling" out of packaging , and two occurred upon a "gentle tug" when removing from packaging.It was reported that the events did not cause a delay the significantly impacted patient care.There was no harm to the user as a result of the event.
Additional Manufacturer Narrative
The customer's report that the secondary tubing sets separated at the drip chamber was confirmed based on visual inspection and handling of the received set samples.The initial separation on one of the four set samples was at the engagement of the drip chamber and tubing components.Slight tugging on each of the other sets tubing to the drip chamber engagement resulted in a separation.Further dimensional analysis of a tubing area of each separated tubing end and the drip chamber spigots were observed to be within specification.The root cause that the secondary tubing sets separated at the drip chamber was due to a combination of factors related to insufficient solvent and improper assembly due to equipment and/or operator error.
Event or Problem Description
It was reported that there were secondary tubing sets that separated at the drip chamber in the emergency department.It was a total of four (4) secondary tubing sets involved, all occurring before patient use.One set separated upon priming of an antibiotic, one occurred while "uncoiling" out of packaging, and two occurred upon a "gentle tug" when removing from the packaging.It was reported that the events did not cause a delay that significantly impacted patient care.There was no harm to the user as a result of these event(s).

• Brand Name: ALARIS SECONDARY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9747849
• Report Number: 9616066-2020-00616
• Device Sequence Number: 16598013
• Product Code: FPA
• UDI-Device Identifier: 10885403235467
• UDI-Public: 10885403235467
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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 Expiration Date: 10/28/2022
• Device Model Number: 72215N
• Device Catalogue Number: 72215N
• Device Lot Number: 19103285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1