MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE),; STOPCOCK, I.V. SET

Model Number MC330428

Device Problems Disconnection (1171); Mechanical Problem (1384)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility mandatory medwatch report # 4633010000-2022-8019 was received that stated: "health care provider was switching the norepinephrine syringe per protocol using the two syringe method and extension tubing.After having the second syringe running for 15 mins to make sure it was engaged, health care provider went to disconnect the tubing from the first extension on the norepinephrine tubing and as health care provider pulled on the clave and tubing, the tubing disconnected from the clave.Health care provider then had to re prime new tubing for the norepinephrine syringe.Patient was running at 0.07mcg/kg/hr.And his blood pressure dropped from mean arterial pressure (maps) of 75 to maps of 55.Health care provider was able to quickly reconnect and get it running again but it took about 6-8 mins to see a bump in patient's blood pressure again.While this was not immediately life threatening for this specific patient if he was more sensitive to changes in this medications it could have required much more intervention and possibly coding the patient".The event occured in the picu and involved a 71" (180 cm) appx 0.44 ml, smallbore ext set w/microclave® clear, clamp (blue), rotating luer.There was patient involvement, however, there was no harm reported.

• Brand Name: 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE),
• 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: 15519843
• MDR Text Key: 306344299
• Report Number: 9617594-2022-00283
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709088344
• UDI-Public: (01)00887709088344(17)270601(10)5997951
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC330428
• Device Catalogue Number: MC330428
• Device Lot Number: 5997951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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: NOREPINEPHRINE SYRINGE, MFR UNK
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 40 KG