MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.70 ML, EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	12515-01
Medical Device Problem Codes	Disconnection (1171); Failure to Deliver (2338)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Thrombosis/Thrombus (4440)
Date of Event	02/20/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient expired in the cath lab due to the microclave® clear tubing not being connected.The facility indicated that they use the product as their primary tubing for 12517-01, 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave¿ clear, purple clamp, rotating luer.The reporter added that they are trying to educate staff and make them aware that this connection is hard to attach and will come apart if not placed properly.The patient was having a cardiac catheterization for an acute myocardial infarction.During the procedure, a heparin bolus was given.The cardiologist noted thrombi building up around the cardiac wires while performing the procedure.Activated clotting time (act) level returned as normal and should have read high after receiving the heparin.The intravenous (iv) site and connections were checked beneath the sterile drapes, and it was found that the iv tubing had become disconnected from the iv extension tubing.Due to the patient not receiving any anticoagulants, thrombi formed within the cardiac artery, which resulted in a cardiac arrest.Resuscitation efforts were not successful, and the patient died.Upon querying the staff who have used this product, we found that it easily becomes disconnected from the iv tubing.No additional information is available at this time.
Additional Manufacturer Narrative
The device is available to be returned for evaluation.However, it has not yet been received.
Additional Manufacturer Narrative
The complaint of disconnection cannot be confirmed.No photos, videos, or samples were returned for evaluation.Multiple attempts were made to receive the reported devices or related samples of the same lot.No additional samples or information were provided.The device history review (dhr) was reviewed and no non-conformities were found that would have led to the reported complaint.Without the return of the used sample/samples, a comprehensive failure investigation cannot be performed.Additional/updated information can be found in d9.

• Brand Name: 7" (18 CM) APPX 0.70 ML, EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER
• 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: 16691497
• Report Number: 9617594-2023-00134
• Device Sequence Number: 6080632
• Product Code: FMG
• UDI-Device Identifier: 00887709047068
• UDI-Public: (01)00887709047068(17)271001(10)11376763
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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: 12515-01
• Device Catalogue Number: 12515-01
• Device Lot Number: 11376763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: 12517-01 SMALLBORE PRESSURE INFUSION, ICU MEDICAL.; HEPARIN, UNK MFR.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown