MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), VENTED CAP; STOPCOCK, I.V. SET

Catalog Number 011-CH3687

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event occurred on an unknown date involving a 41 cm (16") bifuse add-on set w/2 bag spikes, 2 clamps (red, blue), vented cap.A non-chemotherapy and normal saline was connected via spike and line (bifuse).When the nurse touched the line to the normal saline bag which disconnected from the spike.Normal saline then leaked onto the floor, whilst infusion kept running.Infusion completed, non-chemotherapy bag replaced with normal saline for a flush.The treatment was completed.The set was used for non-chemotherapy treatment infusion.The customer also mentioned that the spike broke off.There was patient involvement and unknown patient harm.

Manufacturer Narrative

D9 - date returned to mfg on 3/18/2024.Received one used 011-ch3687 bifuse add-on set w/2 bag spikes and three new 011-ch3687 bifuse add-on set w/2 bag spikes.No defects or anomalies noted.The used set was leak tested per product specifications.The bag spike and tubing separated under pressure on the blue clamp line causing leakage.There appeared to be gaps in solvent coverage on the tubing bond connection.The other bag spike line and new sets were tested for bond integrity.The other line and sets met product specifications.The reported complaint of separation can be confirmed on the used set.The probable cause is due to insufficient solvent coverage during manual assembly in manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 41 CM (16") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), VENTED CAP
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18797711
• MDR Text Key: 336443394
• Report Number: 9617594-2024-00203
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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 Catalogue Number: 011-CH3687
• Device Lot Number: 13689759
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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: "NON-CHEMOTHERAPY", MFR UNK; NORMAL SALINE, MFR UNK