MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15 CM) APPX 0.90 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE CLEAR, 0.2 MI; STOPCOCK, I.V. SET

Catalog Number	MC330209
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/06/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The event involved a 6" (15 cm) appx 0.90 ml, smallbore trifuse ext set w/3 microclave® clear, 0.2 micron filter, 1.2 micron filter, 3 clamps (blue, yellow, white), rotating luer, that during infusion, the 1.2 micron filter infusing lipids clogged, allowing no fluid to go through it.Total parenteral nutrition (tpn) was being infused via the 0.2 micron filter of the device.The tubing set had been in use for less than 24 hours.The set-up of the device was a syringe containing lipids with an extension set attached to the 1.2 micron filter (part of the tri-fuse) that clogged.It was reported that the tri-fuse extension set containing the clogged filter was replaced.It was reported that the patient, a baby, has died, but not as a result of the filter being clogged.The baby became acidotic as a result of dehydration.The date of death is unknown.

• Brand Name: 6" (15 CM) APPX 0.90 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE CLEAR, 0.2 MI
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10631293
• Report Number: 9617594-2020-00429
• Device Sequence Number: 3258828
• Product Code: FMG
• UDI-Device Identifier: 00887709080546
• UDI-Public: (01)00887709080546(17)241101(10)4447222
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Catalogue Number: MC330209
• Device Lot Number: 4447222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death