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

Device Problems Fluid/Blood Leak (1250); Failure to Power Up (1476)

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

Event Description

Spontaneous communication from pharmacy nurse (b)(6) stating that one of pt's pumps need to be replaced.Nurse states that pt had a prefilled cassette in a bag with his back up pump, but the cassette thawed/leaked and got the backup pump wet.Now the pump will not start.Called and spoke to pt.Pt states that he does not have the malfunctioning pump nearby, and he is afraid to mess with the current pump infusing to check the serial number since that is the only working pump he has.Requested that pt call back with the pump serial number when he can for the bad pump.Pt does not have the leaking cassette and lot number is unknown.No interruption in therapy.No further information provided.No side effects reported.Pump- 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.Die 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.Pump- 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.Die we [mfr] replace cassette? no.Did the patient have additional cassettes 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? resolved, ongoing? reports to cvs/caremark by: health professional.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 14874375
• MDR Text Key: 295137155
• Report Number: MW5110610
• 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: 06/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male