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

Model Number AM3014

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

Rn noted patient blood pressure had decreased significantly while she was assisting another patient.Upon arrival to bedside, manifold piece had disconnected from manifold, causing vasopressor to subsequently into floor instead of patient.Patient complained of unwell feeling due to significant drop in blood pressure due to unintended interruption of medication.Manufacturer response for set ext nanoclave manifold 26" clear microclave x2 *custom*, (brand not provided) (per site reporter): emailed.

• 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: 14159796
• MDR Text Key: 289681205
• Report Number: 14159796
• 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: 03/11/2022

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 Model Number: AM3014
• Device Catalogue Number: AM3014
• Device Lot Number: 5162807
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2022
• Date Report to Manufacturer: 04/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Female