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

Lot Number 3983334

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Event Description

Spontaneous call from patient reporting cassette had major holes and leaked mixed drug and diluent lot 3983334, expiration 06/19/2025.No adverse effects reported.Patient has other cassettes to use.Did the reported product fault occur while in use with the patient? - no; did the product issue cause or contribute to patient or clinical injury?- no; is the actual device available for investigation? -yes; did we [mfr] replace device?-yes; did the patient have a backup device they were able to switch to? -yes; if yes, was the patient 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: CASETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10762311
• MDR Text Key: 214113143
• Report Number: MW5097558
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3983334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1