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

Model Number	10012144
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
Event or Problem Description
It was reported that the nurse initiated a tpn infusion in which the device continuously alarmed for air in line.While troubleshooting, the tubing set separated at the upper fitment and leaked tpn on the nurse and patient.
Additional Manufacturer Narrative
Continued from e3-registered respiratory therapist additional information added to :d4,h4 a1, a2, a3, a4, b3, b6 and b7 were requested but not provided.
Event or Problem Description
It was reported that the nurse initiated a tpn infusion in which the device continuously alarmed for air in line.While troubleshooting, the tubing set separated at the upper fitment and leaked tpn on the nurse and patient.Although requested, there was no reported impact to the patient or user available to date.
Additional Manufacturer Narrative
No device will be returned.Photo provided by the customer shows the location of the tubing separation could not be determined.The root cause of this failure was not identified.Device history record for model 10012144 lot 20025733 shows that the set was manufactured on 12 february 2020 with a total of 3,843 units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.
Event or Problem Description
It was reported that the nurse initiated a tpn infusion in which the device continuously alarmed for air in line.While troubleshooting, the tubing set separated at the upper fitment and leaked tpn on the nurse and patient.Although requested, there was no reported impact to the patient or user available to date.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMIN, INTRAVASCULAR.
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10155023
• Report Number: 9616066-2020-01927
• Device Sequence Number: 2680703
• Product Code: FPA
• UDI-Device Identifier: 07613203021159
• UDI-Public: 7613203021159
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2020

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: 02/12/2023
• Device Model Number: 10012144
• Device Catalogue Number: 10012144
• Device Lot Number: 20025733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/06/2020; 08/05/2020
• 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: 8015,8100, THERAPY DATE UNKNOWN