MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE CLEAR, 3 CLAM; STOPCOCK, I.V. SET

Catalog Number MC33098

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device is available for investigation.It has not been received.

Event Description

The event involved a 4" (10 cm) appx 0.40 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, rotating luer that the customer reported a partial disconnection and leaking resulting in hypoglycemia of a baby in the nicu.The medications infusing were tpn, lipids, and d20w.The d20w was infusing for only 4 hours and was unknowingly leaking.The customer stated the device was in use between 18 to 36 hours.The patient¿s status upon admission was hypoglycemia.During the event the patient was borderline stable then hypoglycemic.The patient returned to a normoglycemic status after the tubing was changed.The medical intervention was the administration of d20w and the decrease of tpn.The entire set up was changed, not the umbilical venous catheter, the patient¿s sugar normalized within an hour, and few hours later the d20w was discontinued.The event did not prolong the hospital stay.

Manufacturer Narrative

H10: received three new sister samples list# mc33098, 4" (10 cm) appx 0.40 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, rotating luer.Lot# 4799556 on (b)(6) 2020 for evaluation.Three (3) new list# mc33098, trifuse ext sets (lot# 4799556) were received and visually inspected.As received, no damage or anomalies were seen.No used devices or mating devices were returned.All three (3) samples were functionally tested.The retention of the male spin luers met the specification performance requirements with no disconnection or leakage identified.The reported complaint could not be replicated or confirmed.A device history review (dhr) lot# 4799556 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE CLEAR, 3 CLAM
• 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
• MDR Report Key: 10572532
• MDR Text Key: 208107860
• Report Number: 9617594-2020-00410
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709037366
• UDI-Public: (01)00887709037366(17)250401(10)4799556
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC33098
• Device Lot Number: 4799556
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BI-FUSE, ICU MEDICAL INC. UNK LIST AND LOT; DEXTROSE 20% IN WATER (D20W), MFR UNK; LIPIDS, UNK MFR; TOTAL PARENTAL NUTRITION, MFR UNK; BI-FUSE, ICU MEDICAL INC. UNK LIST AND LOT; DEXTROSE 20% IN WATER (D20W), MFR UNK; LIPIDS, UNK MFR; TOTAL PARENTAL NUTRITION, MFR UNK
• Patient Outcome(s): Required Intervention