MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SET, ADMIN, CADD, 130", EPID, SPIKE, 0.2 FLTR, YELLOW STRIPE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7339-24
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Underdose (2542)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical administration set was implicated in a medication not being delivered to the patient.The patient was not getting comfortable.It was discovered that no medication was being delivered by viewing the medication contained despite the pump indicating medication was being delivered.There were no adverse events reported due to this event.
Additional Manufacturer Narrative
Returned device was received in excellent physical condition.No evidence of reported problem in event log was found.During the evaluation of the device, analysts were unable to duplicate the reported issue.The bottom case was found to have a loose screw which was promptly tightened.Otherwise, no fault was found with the system.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: SET, ADMIN, CADD, 130", EPID, SPIKE, 0.2 FLTR, YELLOW STRIPE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9908429
• Report Number: 3012307300-2020-02430
• Device Sequence Number: 644222
• Product Code: FPA
• UDI-Device Identifier: 10610586027307
• UDI-Public: 10610586027307
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: No Information
• Device Expiration Date: 10/07/2024
• Device Model Number: 21-7339-24
• Device Lot Number: 3882432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/19/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1