MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAMPS, LUER LOCK; STOPCOCK, I.V. SET

Model Number	Z3535
Medical Device Problem Codes	Fluid/Blood Leak (1250); Retraction Problem (1536)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	01/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
The event involved a 7" smallbore trifuse ext set w/3 microclave® clear, 3 clamps, luer lock, where it was reported that the rubber piece of clave remained pushed down and did not retract when removing medication from line.This resulted in vasopressors leaking out of the clave and not reaching a critically ill patient, requiring multiple medications for hemodynamic stability.The patient had a drastic abrupt drop in blood pressure requiring swift medical interventions for hemodynamic support and stability.
Additional Manufacturer Narrative
The device history lot review (dhr) for lot 12179054 was reviewed and no non conformities were found that would have led to the reported complaint.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.
Event or Problem Description
Additional information received stating the primary diagnosis of the patient is ascending aortic dissection with no preexisting conditions.The patient arrived in ccu at 2240 on 1/29 and the event was entered for 0525 on 1/30.The status of the patient prior to the event was hemodynamically stable with a blood pressure (bp) via art line 93/51, map 65.One vasopressor present - levophed at 0.17 mcg/kg/min.Emergent medical treatments that were required were as follows: 1.Bp dropped to 53/34 via art line, map 41.2.Epinephrine gtt added at 0.02 mcg/kg/min.3.Vasopressin gtt added at 0.04 units/min.No issues were noted during the initial priming/set-up of the affected product.The approximate location on the z3535 trifuse ext.Set where the clave seal remained recessed and leakage was observed was on portion 4.The patient current status is deceased, the exact date of death was not reported by the customer.

• Brand Name: 7" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAMPS, LUER LOCK
• Common Device Name: 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16655112
• Report Number: 9617594-2023-00129
• Device Sequence Number: 15104776
• Product Code: FMG
• UDI-Device Identifier: 00887709033207
• UDI-Public: (01)00887709033207(17)271101(10)12179054
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Z3535
• Device Catalogue Number: Z3535
• Device Lot Number: 12179054
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 04/28/2023; 05/26/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/09/2023; 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EPINEPHRINE, UNK MFR; LEVOPHED, UNK MFR; UNSPECIFIED VASOPRESSORS, UNK MFR; VASOPRESSIN, UNK MFR
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 54 YR
• Patient Sex: Female