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

Lot Number 4235253

Device Problems Failure to Infuse (2340); Protective Measures Problem (3015)

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

Event Type  malfunction  

Event Description

Unsolicited communication: pt reports pump alarmed with double beeping last week.She tried to troubleshoot the cassette but would not infuse on either pump.She replaced cassette and resumed infusing.No issues with pump.Cassette lot number: 4235253.This is the 3rd cassette malfunction in the last month.(previous issues have been reported.) pt does not need pharmacy field nurse.Pump was in use when fault occurred.No lapse in infusion or side effects due to malfunction.Pt does have cassette available for return.Patient does have back up cassettes.Infusion is life-sustaining.Outcome: resolved.Photographs were not provided.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.This is a continuous infusion.All known information is contained on this form.If any additional information is received it will be provided on a separate report.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? yes; did we [mfr] replace the cassette? per pt, at next order; did the pt have add'l cassettes 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.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: 14592764
• MDR Text Key: 293459065
• Report Number: MW5110070
• 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: 05/27/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4235253
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2022
• Patient Sequence Number: 1
• Patient Sex: Female