MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE EXT SET W/MICROCLAVE®, MICROCLAVE® T-CONNECTOR, CLAMP, ROTATING LUE; STOPCOCK, I.V. SET

Model Number Z1120

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.

Event Description

The event occurred on an unspecified saturday evening and involved a 7" smallbore ext set w/microclave®, microclave® t-connector, clamp, rotating luer.The customer reported that the intravenous (iv) tubing was leaking which resulted in blood loss on a neonate in icn 08.It was stated that the nurse went to give medications at 8 pm and saw that a small amount of total parental nutrition (tpn) and blood mixture had collected in the small tray in the patient's bed.Upon further investigation of the tubing and connections, the connections were found to be tight, but the fluids and blood were leaking at the hub.The device was then switched out and the neonatal nurse practitioner (nnp) was notified.About an hour later, the patient's blood pressure dropped and the nnp was notified again.A bolus of medication was then administered.The staff took the giraffe apart down to the area near the fan and they found a decent amount of blood and tpn that had accumulated there.All of the leakage was not initially visible because the connection was towards the bottom of the mattress and some leakage was later found in between parts of the patient¿s bed.The patient required a blood transfusion.The physician arrived to check on the baby and upon further investigation at that time, it was confirmed again that the connector was leaking.There was patient involvement and no harm.

• Brand Name: 7" SMALLBORE EXT SET W/MICROCLAVE®, MICROCLAVE® T-CONNECTOR, CLAMP, ROTATING LUE
• 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: 12819243
• MDR Text Key: 280962238
• Report Number: 9617594-2021-00297
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709022409
• UDI-Public: (01)00887709022409(17)260501(10)5353139
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z1120
• Device Catalogue Number: Z1120
• Device Lot Number: 5353139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• 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
• Treatment: GIRAFFE INCUBATOR, MFR UNK; UNSPECIFIED TPN, MFR UNK