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

Device Problem Failure to Infuse (2340)

Patient Problem Death (1802)

Event Date 09/06/2020

Event Type  Death  

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 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
• Type of Device: 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10631293
• MDR Text Key: 209938444
• Report Number: 9617594-2020-00429
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709080546
• UDI-Public: (01)00887709080546(17)241101(10)4447222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC330209
• Device Lot Number: 4447222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death