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 container despite the pump indicating medication was being delivered.There were no adverse events reported due to this event.
Additional Manufacturer Narrative
Evaluation results: one cadd administration set was returned for investigation in used condition.The samples were visually inspected at a distance of 12 to 16 inches and under normal conditions of illumination.No obstructions or other workmanship defects were detected in any of the joins of the product.Only a kink was detected on the pump tube.The samples were tested using a hydrostat vessel to look for unusual function.No discrepancies were detected.The entire sets was successfully primed.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.The most probable root cause of the product problem is that the pump tube become affected after it left the manufacturing facility.

• 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: 9908435
• Report Number: 3012307300-2020-02431
• Device Sequence Number: 19005362
• 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): 05/18/2020

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: 03/04/2020
• 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: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1