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

Model Number	2120-0500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Tubing lot requested however not provided.Requested initials, date of birth, diagnosis.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the patient called the nurse to the room because the iv pump was leaking upon investigation, the nurse discovered that the iv tubing had become disconnected inside the channel during basic infusion the tubing became disconnected at the first blue site distal to the spiked 500cc bag of d51/2 the wrapping was not able to be located for the lot number." an incomplete date of event of (b)(6) 2019 was provided.".
Event or Problem Description
It was later reported by the rn that stated : "d5 ½, was programmed at kvo rate at 10/hr.And had been ordered to be running with pca since (b)(6) 2019".The customer was unsure how long the set was in use as per policy likely the tubing was 4-7 days."a new bag of fluids hung at time of event, the patient had been in hospital for quite some time, the set was loaded properly, no different than any other load¿.There was no patient harm per customer, event occurred medical/surgical unit.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9492750
• Report Number: 9616066-2019-03691
• Device Sequence Number: 2981869
• Product Code: FPA
• UDI-Device Identifier: 07613203012690
• UDI-Public: 7613203012690
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 2120-0500
• Device Catalogue Number: 2120-0500
• 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: 12/19/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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.; 8110, PCA TUBING, SYRINGE.
• Patient Age: 40 YR
• Patient Weight: 95