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

Device Problems False Alarm (1013); Defective Device (2588)

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

Event Type  malfunction  

Event Description

Patient called to report that her pump is alarming for non-disposable.I had the patient try the cassette in her other pump which gave the same error, leading us to believe that the issue is a cassette error and not a pump error.The patient said this happened 2 cassettes ago as well.Her cassettes were at remaining volumes of 20 and 40 mls when this alarm occurred.Explained that it may be the pump bladder interfering.Advised that she reach out to cnss to see if they can assess if her cassette bladder is interfering with this and the technique to have her self resolve it if it happens again.We are sending her replacement cassettes.Patient will call back and ask for new pump if issue continues to recur.Serial numbers are unknown.Patient made new mix and was able to continue infusion.No other information is known at this time.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? no; did we [mfr] replace the device? yes; did the pt have add'l backup device they were able to switch to? yes; was the pt able to successfully continue their infusion? yes; reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MIDI RESEVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15498707
• MDR Text Key: 300784423
• Report Number: MW5112284
• 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: 08/29/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2022
• Patient Sequence Number: 1
• Treatment: PUMP; REMODULIN ; TUBING
• Patient Sex: Female