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

Catalog Number UNKNOWN

Device Problems Connection Problem (2900); Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Event Description

Unsolicited communication from patient¿s fiancé who stated cadd legacy pump alarmed after 24 hours for no disposable (not detecting cassette).Patient able to switch to backup.Advised pump alarmed correctly, finding this to be cassette issue.Patient still had half cassette attached to alarming pump.Unknown if cassette is available for return.Advised to push corner of internal bladder back into hard cassette.This flattens tubing of cassette and improves contact with sensor on pump.Cassette lot #43-81662.Event is for one cassette.Cassette number provided by finance.Photographs were not provided.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred is unknown.This is a continuous infusion.Pump return tracking information is not available.No additional information is available at this time.Did the reported product fault occur while in us with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.If yes, was any medical intervention provided? n/a.Is the actual device available for investigation? unknown.Did we replace device? no.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.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): MINNEAPOLIS MN SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15198282
• MDR Text Key: 297765141
• Report Number: MW5111398
• 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: 08/05/2022

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 42-81661
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2022
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female