MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; STOPCOCK, I.V. SET

Model Number MC330428

Device Problem Disconnection (1171)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

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.

• Brand Name: ICU MEDICAL
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 15334736
• MDR Text Key: 299060613
• Report Number: 15334736
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MC330428
• Device Catalogue Number: MC330428
• Device Lot Number: 5997951
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2920 DA
• Patient Sex: Male
• Patient Weight: 40 KG