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

Device Problems Infusion or Flow Problem (2964); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Event Description

Patient reported no disposable alarm on the pump, advised patient to run fix for no disposable by "poking that little portion of bladder back into cassette with pen or pencil, which allows cassette to be more flush against sensor." patient tried that and error was cleared.Patient did not want to order any supplies and was comfortable with not replacing pump and will call back if any further issues.No other information provided.Alarm on the pump was caused by cassette, pouch inside cassette was poking out of the cassette.Unk lot number or expiration date of the cassette.Pump return tracking information is not applicable.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is unknown.No additional information is available at this time.Did we replace the product? no; did the pt have a backup product they were able to switch to? issue with reported product was resolved.Was the pt able to successfully continue their therapy? yes; is the therapy life-sustaining? yes.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 product available to be returned for investigation? no; what is the outcome of the event? fixed, no disposable error.Describe in detail any, and all damage to the cassette: na; has this incident happened within the past 6 months? no; has this pt reported pump malfunction within the past 6 months: no.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDICATION RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 15932880
• MDR Text Key: 305068276
• Report Number: MW5113661
• Device Sequence Number: 1
• 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: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male