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

Device Problem False Alarm (1013)

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

Event Type  malfunction  

Event Description

Unsolicited communication: patient called in to report that an alarm went off on her pump.Patient was not sure what the alarm was.Patient said it has happened twice in the last 8 hours.Patient states the alarm, stops once she pushes on the bladder in the cassette.Advised patient to ensure no kinks or blockage in the line and that no clamps were closed on line.Patient stated no issues.Patient states pump is running fine now.Advised patient if it happens again to see what the message alarm reads and call back.Patient voiced understanding and had no other questions.Photographs were not provided.Set flow rate and volume delivered are unk.Position of the pump when alarm occurred is unknown.This is a continuous infusion.Return tracking information is not available.No additional information is available at this time.Event is for cassette only.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? no; is the actual device available for investigation? yes; did we [mfr] replace the device? yes; did the pt have a backup device 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; reported to cvs/caremark 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: 15536694
• MDR Text Key: 301173152
• Report Number: MW5112383
• 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: 09/01/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2022
• Patient Sequence Number: 1
• Patient Sex: Female