MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Increase in Pressure (1491); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2020

Event Type  malfunction  

Event Description

Patient reported that when she mixed her cassette this morning and went to prime the pump alarmed high pressure.The patient then switched to alternate pump and got the same error when priming.Patient then mixed another cassette and was able to prime and infuse.No pump issues.Patient did not have lot information for cassette.No other information available.Did the pt have a backup device they were able to switch to? not necessary.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.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? unk.Is the actual device available for investigation? no.Did we (mfr) replace the device? no.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10338365
• MDR Text Key: 201064625
• Report Number: MW5095779
• Device Sequence Number: 1
• Product Code: FPA
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 76 YR