MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDICATION RESERVOIR; SET, I.V. FLUID TRANSFER

Lot Number 4329619

Device Problem Nonstandard Device (1420)

Patient Problems Dyspnea (1816); Malaise (2359)

Event Type  Injury  

Event Description

Patient reported she has 18 affected cassettes with lot numbers: 4315909, 4321042, 4299613 (expiration dates not specified).Patient has 30 good cassettes with lot number 4329619 (expiration date not specified).Patient said she is unsure if the cassette she is currently infusion with was affected as she does not have the lot number, but she did say she has been feeling sick for the last month (tested negative for flu/covid-19, thinks she might have respiratory syncytial virus), and she said 2 days ago her breathing was not okay, but it has improved since then.She is unsure whether it is related to her illness or the cassettes now.Advised patient to switch to an unaffected cassette as soon as possible, and to call md/pharmacy with any symptoms or side effects, or if severe product lot number and expiration date were systematically retrieved from the dispensing system.Got to hospital.Patient understood.Practice i also notified to inform md as well.No further information provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is not applicable.No additional information is available at this time.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? yes.If yes, was any medical intervention provided? no.Is the actual cassette available for investigation? yes.Did we replace the cassette? no-pt.Has 30 on hand still.Did the patient have additional cassettes they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.If no, what was the patient instructed to do in able to continue their infusion? n/a.Is the infusion life-sustaining? yes, what is the outcome of the event? ongoing.Resolved? ongoing? reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE MEDICATION RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16016749
• MDR Text Key: 306036167
• Report Number: MW5113874
• Device Sequence Number: 44
• Product Code: LHI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2022
• 48 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4329619
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female