MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12 CM (5") PUR SMALLBORE TRIFUSE EXT SET, 3 CHECK VALVES, 3 CLAMPS, ROTATING LUE; STOPCOCK, I.V. SET

Catalog Number 011-H3424

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/10/2024

Event Type  malfunction  

Event Description

The complaint/event occurred on an unspecified date and involved a 12 cm (5") pur smallbore trifuse ext set, 3 check valves, 3 clamps, rotating luer.The following issue was reported by the customer: noradrenaline was placed in an electric syringe pump with the extension set for a patient operated for abdominal aortic aneurysm under general anesthesia in a septic context.Backflow of blood in the lines was observed; the check valve was nonfunctional, there was leakage, blood loss and loss of infusate.There was no human harm reported as a result of this complaint/event.

Manufacturer Narrative

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

Manufacturer Narrative

Additional/updated information can be found in b3, b5 and d4.Two new samples of list #011-h3424 were returned by the customer for evaluation.No mating device was returned for evaluation.As received, no physical damage or anomalies were observed.The sets were tested and met product specifications, no issues or anomalies were confirmed.This supplemental emdr reflects the testing for the new/unused returned sample #2.The customer identified a possible lot number (plot) as follows: (b)(4) (expiry date (b)(6) 2023, mfr date (b)(6) 2023) d9 - date returned to mfg: (b)(6) 2024.

Event Description

The customer provided additional information on (b)(6) 2024 stating that the issue/event occurred on (b)(6) 2024.The customer also stated that that there were no harm/adverse events for the patient, no need for any additional medical intervention and no blood loss.There was a delay in therapy for a few minutes, approximately the time to stop the injection, remove and change out the device and then to inject the therapies one by one.

Manufacturer Narrative

Additional/updated information can be found in b3, b5 and d4.Two new samples of list #011-h3424 were returned by the customer for evaluation.No mating device was returned for evaluation.As received, no physical damage or anomalies were observed.The sets were tested and met product specifications, no issues or anomalies were confirmed.This supplemental emdr reflects the testing for the new/unused sample #1.The customer identified a possible lot number (plot) as follows: 13809062 (expiry date 10/1/2023, mfr date 10/1/2023).

Event Description

The customer provided additional information on march 06, 2024 stating that the issue/event occurred on (b)(6) 2024.The customer also stated that that there were no harm/adverse events for the patient, no need for any additional medical intervention and no blood loss.There was a delay in therapy for a few minutes, approximately the time to stop the injection, remove and change out the device and then to inject the therapies one by one.

• Brand Name: 12 CM (5") PUR SMALLBORE TRIFUSE EXT SET, 3 CHECK VALVES, 3 CLAMPS, ROTATING LUE
• 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: 18839511
• MDR Text Key: 336962693
• Report Number: 9617594-2024-00231
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 04/04/2024

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-H3424
• Device Lot Number: PLOT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/06/2024; 03/06/2024
• Supplement Dates FDA Received: 04/04/2024; 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: NORADRENALINE, MFR UNK; UNSPECIFIED ELECTRIC SYRINGE PUMP, MFR UNK