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

Device Problem Increase in Pressure (1491)

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

Event Type  Injury  

Event Description

Spontaneous: inbound from pt spouse reporting that the two veletri pumps are giving high pressure on connecting cassettes.Transferred her to (b)(6) for further assistance, going to (b)(6) hospital at (b)(6).Wife's (b)(6).Infusion stopped about 1 hr ago.Patient is getting high pressure alarm, on both the pumps.No kinks, clamps open, changed tubing and cassettes.Tubing placed correctly.Patient understands at this point this could be central line blockade and headed to hospital on recommendation.Patient is taking drug/cassettes and supplies with her to er.Called hospital er spoke to (b)(6).They are aware and is expecting patient.Product lot number and expiration date were systematically retrieved from the dispensing system.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? yes; if yes, was any medical intervention provided? yes; is the actual product available for investigation? unk; did we [mfr] replace the product? 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? unk; if no, what was the pt instructed to do in able to continue their infusion? go to the hospital.Is the infusion life sustaining? yes; what is the outcome of the event? hospitalization.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: 16214735
• MDR Text Key: 307943206
• Report Number: MW5114395
• 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: 01/14/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2023
• Patient Sequence Number: 1
• Treatment: VELETRI
• Patient Sex: Male