MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 4152716

Device Problems Fluid/Blood Leak (1250); Failure to Read Input Signal (1581); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Solicited call; patient reported faulty cassette lot #4120065 (after she mixed, it wouldn't read in both pump).Patient used new cassette with different lot number and it worked fine.Also, faulty tubing lot# 4152716 [leaked by the disc in 2 tubing from same lot number].Patient switched to another tubing from different lot# and it worked fine.No side effect reported.No interruption in treatment reported.Exact date: unknown.No other information provided at this time.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? no; did we [mfr] replace the device? yes; did the pt have add'l cassettes they were abel to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.

• Brand Name: TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12681900
• MDR Text Key: 278346150
• Report Number: MW5104862
• Device Sequence Number: 2
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/18/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 4152716
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1