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

Model Number	C70101
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient was an adult.No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that while administering album via a secondary set to a patient, the tubing would not flow (prime).When the nurse finally got the tubing to prime, it still would not drip from the line on the pump or free flow with the clamp open.The nurse finally clamped the primary tubing to initiate flow from the secondary tubing.A half hour infusion turned into an hour and a half.There was no harm to the patient.

• 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: 8899351
• Report Number: 9616066-2019-02301
• Device Sequence Number: 1504326
• Product Code: FPA
• UDI-Device Identifier: 10885403235733
• UDI-Public: 10885403235733
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

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 Expiration Date: 03/30/2020
• Device Model Number: C70101
• Device Catalogue Number: C70101
• Device Lot Number: 17038084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR