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

Device Problem No Flow (2991)

Patient Problem Underdose (2542)

Event Date 01/31/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9908429
• MDR Text Key: 185905302
• Report Number: 3012307300-2020-02430
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027307
• UDI-Public: 10610586027307
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• 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
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 04/19/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1