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

Lot Number 4298336

Device Problems Nonstandard Device (1420); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Patient reported he has 7 units of cassettes lot number: 4329619 that are not affected, and have 7 units of cassettes lot number: 4298336 expiration date not provided that are affected.Patient reported there have been a couple times where alarm has gone off and stopped the pump.Patient sometimes feels worse at times (no further details provided regarding this, unspecified if it is related to potential punlj/cassette complaint being reported).Replacement cassettes scheduled.Fy"pe of pump alarm patient experienced is unk.Patient did not report how he resolved the alarms, if he changed to a new cassette or pump.Patient did not specify what cassette lot number was in use when alarm was going off.Unknown whether punlj or cassette was causing the alarm to go off.Unknown serial number/due date of pump.Pump return tracking info is not available.Photographs were not provided.This is a continuous infusion.Setflow rate and volume delivered are unk.Position of pump when alarm occurred is unk.No add'l info is available 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? pt also reporting side effect.Unspecified if due to pump/cassette issues.If yes, was any medical intervention provided? no; is the actual product available for investigation? unk.Did we [mfr] replace the product? yes, cassettes.Did the pt have a backup product they were able to switch to? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16026016
• MDR Text Key: 306076199
• Report Number: MW5113890
• 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: 12/15/2022
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4298336
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male