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

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Event Description

Patient reported she has all affected lots: 4298336, 4295882, 4315909, 428465, 4291411 [expiration dates unknown].Patient stated she did get a few "no disposable attached" alarms recently but was able to fix the issue/continue infusion.She is due to change her cassette very soon.Currently patient has no symptoms.Advised patient we are recommending to go to hospital since we will not be able to get a good cassette out to patient in time.Patient says she has been using them so far, so she understands it's her risk to take.Rph will notify practice liaison to inform md of patient decision.Unknown which lots caused the alarm.Unknown how patient was able to fix the issue.Unknown which pump used at time issue occurred, serial number/due date unknown.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 product available for investigation? yes; did we [mfr] replace the product? yes; did the pt have a backup product they were able to switch to? no, all cassettes on hand are impacted lots.Was the pt able to successfully continue their therapy? yes, using impacted lot at her risk.Is the therapy life sustaining? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16068113
• MDR Text Key: 306424832
• Report Number: MW5114059
• Device Sequence Number: 2
• Product Code: LHI
• Combination Product (y/n): N
• 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: 12/20/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

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: 12/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female