MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 21730224

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Via spontaneous call, patient's wife reported faulty cassettes.She stated that when they push the syringe containing drug/ diluent into the cassette (lot 21730224), the medication leaks from the connector and within the cassette.She said that it looks like the cassette pops from the inside.She can see solution outside of the cassette's inner bag.She said this is the 5th time this has happened since switching from (b)(6).Pt currently has 2 mixes already made and they are going to try to make one more mix as backup mix, but they are concerned because they are having to waste drug due to these faulty cassettes.Asked patient's wife if they had extra cassettes that are of a different lot number.She stated they are all the same lot - 21730224.Advised her that we will ship 30 cassette medi reservoirs of a different lot and see if that fixes this issue.No other information or dates known.Did the pt have a backup device they were able 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.Did the reported product fault occur while in use with a pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual device is available to be returned for investigation? yes.Did we replace device? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12624128
• MDR Text Key: 276644169
• Report Number: MW5104548
• Device Sequence Number: 4
• 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: 04/30/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

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 Lot Number: 21730224
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1