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

Device Problem No Flow (2991)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

Spontaneous call from patient to report pump cadd legacy beeping.Patient states that the new pump she received from us is beeping/alarming with no disposable, pump won't run.Advised patient that the issue is most likely the cassette she is using since we have been having issues with defective cassettes for the past few months.Patient states she last mixed on (b)(6) 2022 with the cassette that is causing alarm now and is due to mix again tonight, advised patient to mix new cassette and to attach new cassette to this pump that is alarming to see if that fixes issue.Advised patient if it did not, to use her back up pump and call us immediately to set up pump replacement if needed.Patient verbalized understanding.Patient did not have lot number of cassette.Serial number of alarming pump: (b)(4).No further information is available.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? yes; 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)/caremark 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: 13995481
• MDR Text Key: 288665442
• Report Number: MW5108720
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFUSION PUMP SN: (B)(4)
• Patient Age: 67 YR
• Patient Sex: Female