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 Type  malfunction  

Event Description

Spontaneous call from patient with a cassette error, pump is working fine per patient.Cassette error (no disposable pump wont run).Patient is advises to change cassette and do a new mix, cassette lot number not available.Did the reported product fault occur while in use with a patient? yes; did the product issue cause or contribute to patient or clinical injury? no; is the cassette available to be returned for investigation? yes; what is the outcome of the event? resolved -describe in detail any, and all damage to the cassette: no physical damage; has this incident happened within the past 6 months? (offer nursing evaluation) yes- 3 times; has this patient reported a pump malfunction within the past 6 months (offer nursing evaluation) yes; pt declined follow up from nursing.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: 13995414
• MDR Text Key: 288599771
• Report Number: MW5108718
• 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
• Patient Sex: Female