MAUDE Adverse Event Report: CAREFUSION MAXGUARD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number ME1225

Device Problem Obstruction of Flow (2423)

Patient Problems Underdose (2542); No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

It was reported that filters are clogging in the nicu.During a patient infusion where the tubing was hung at (b)(6) 2019 at 2200, cefepime 350 mg (8.75ml) was the antibiotic infusing for over 30 minutes.After 16 hours, smof lipids running at 5ml/hour.The 1.2 micron filter were clogged.(b)(6) 2019 at 1400, the pump continued to alarm that the infusion was occluded and the last dose of antibiotics was (b)(6) 2019 at 2130.The issue did not resolve until a new filter was hung.As an end result, the patient did not receive the total volume of lipids ordered due to the delays and need for filter changes.

Manufacturer Narrative

The customer¿s report that the filters are clogging and the pump continued to alarm that the infusion was occluded was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.White liquid (lipids) was observed in the set¿s tubing and 1.2 micron filter.Functional testing was performed; the device noted an occlusion alarm during the infusion.The extension set was soaked in warm water for ten minutes and then the white liquid (lipids) was flushed out of the set¿s micron filter.The lab iv bag with lipid solution was reattached to the lab primary set allowing the fluid to flow through the sets via gravity.It was observed that the fluid flowed freely and primed the set completely.The root cause of the lipid filter occluding has been identified as the filter becoming occluded over time and repeated use due to the build-up of infusion particulates.

Event Description

It was reported that filters are clogging in the nicu.During a patient infusion where the tubing was hung at (b)(6) 2019 at 2200, cefepime 350 mg (8.75ml) was the antibiotic infusing for over (30) minutes.After (16) hours, smof lipids running at 5ml/hour, the 1.2 micron filter was clogged.On (b)(6) 2019 at 1400, the pump continued to alarm that the infusion was occluded and the last dose of antibiotics was (b)(6) 2019 at 2130.The issue did not resolve until a new filter was hung.As an end result, the patient did not receive the total volume of lipids ordered, due to the delays and need for filter changes.

Manufacturer Narrative

Correction to section b.3, on initial report.

Event Description

It was reported that filters are clogging in the nicu.During a patient infusion where the tubing was hung at (b)(6) 2019 at 2200, cefepime 350 mg (8.75ml) was the antibiotic infusing for over (30) minutes.After (16) hours, smof lipids running at 5ml/hour, the 1.2 micron filter was clogged.On (b)(6) 2019 at 1400, the pump continued to alarm that the infusion was occluded and the last dose of antibiotics was (b)(6) 2019 at 2130.The issue did not resolve until a new filter was hung.As an end result, the patient did not receive the total volume of lipids ordered, due to the delays and need for filter changes.

• Brand Name: MAXGUARD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9322687
• MDR Text Key: 190507727
• Report Number: 9616066-2019-03259
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ME1225
• Device Catalogue Number: ME1225
• Device Lot Number: 19086260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 MO