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

Model Number 6400

Device Problem Infusion or Flow Problem (2964)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Event Description

Spontaneous: spoke with patient and her husband regarding patient feeling unwell.When patient was changing her cassette, the pump displayed the message no disposable, clamp tubing.Patient states she immediately made another cassette and attached on the back up pump.She was able to continue infusion without disruption.During troubleshooting with pump, patient states she "bolus-d" and felt unwell after.Unknown how she bolus-d herself.Advised patient to take her blood pressure and it was 91/48.Confirmed pump rate to be 44ml/24hr on pump.Waited on the line and advised patient to take another blood pressure reading and returned to normal 107/64 after 15 minutes.Advised patient to monitor blood pressure.At the end of the call, patient states her breathing is fine and feels stable.Malfunction pump sn# (b)(4).Cassette lot# 4163625.Patient requests urgent shipment of backup pump and pump return box.No other information known.Did the product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? yes; pt unknowingly infused bolus of medication.If yes, was any medical intervention provided? no; is the actual cassette available for investigation? no; did we replace the cassette? no; 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) 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: 14576213
• MDR Text Key: 293313672
• Report Number: MW5110055
• 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: 05/30/2022
• 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?: Yes
• Device Model Number: 6400
• Device Lot Number: 4163625
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2022
• Patient Sequence Number: 1
• Patient Sex: Female