MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 11 CM (4") SMALLBORE BIFUSE PUR YELLOW/CLEAR EXT SET W/2 4-WAY STOPCOCKS, 3 CHEC; STOPCOCK, I.V. SET

Catalog Number 011-H3523

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 10/09/2023

Event Type  Injury  

Event Description

The event occurred at 22:13h involving a 11 cm (4") smallbore bifuse pur yellow/clear ext set w/2 4-way stopcocks, 3 check valves, rotating.The reporter stated, while wanting to relay noradrenaline on the new relay octopuses, the nurse carried out the priming as usual, but one of the 2 taps cannot prime so when the tap was opened the patient received a bolus of noradrenaline.The patient went into ventricular fibrillation with absence of tension on the arterial catheter but returned to a normal rhythm without external intervention from the team caregiver.Actions immediate carried out: ecg + blood test + heart echo.The product is not available for evaluation.The status of the product at the time of event is during priming.The incident was observed immediately.It was noticed a ventricular tachycardia as an undesirable clinical consequence.As additional medical intervention required following this incident was ecg + blood test + heart echo.It was unknown if was a delay in therapy.The therapy has been completed.The patient had a favorable clinical evolution after the incident.The patient did not receive the full intended dose, but an overdose.

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.The device history record for lot 5420097 was reviewed and there were no relevant non-conformance's found that would have contributed to the reported complaint.

• Brand Name: 11 CM (4") SMALLBORE BIFUSE PUR YELLOW/CLEAR EXT SET W/2 4-WAY STOPCOCKS, 3 CHEC
• 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: 18160075
• MDR Text Key: 328405284
• Report Number: 9617594-2023-00991
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619066536
• UDI-Public: (01)00840619066536(17)260501(10)5420097
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3523
• Device Lot Number: 5420097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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: ARTERIAL CATHETER, MFR UNK; NORADRENALINE, MFR UNK
• Patient Outcome(s): Life Threatening