MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VALVES, 3ML FLU; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42800-35
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation- the investigation is pending.
Event or Problem Description
The event involved a transpac¿ it monitoring kit, 84" safeset reservoir, 2 needleless valves, 3ml flush device, macrodrip where the customer stated in the report with ynhhs tracker # (b)(4) and safer # (b)(4) that an a-line setup was defective with a break in the system resulted in leaking.The patient deteriorated during the day and a-line was changed during change of shift.Tiny break in a-line tubing and it was noted after attached to the patient.This was a transducer tubing used for arterial blood pressure monitoring.The teams identified that it was leaking at one of the connections after the rn could not flush the transducer tubing.The status of the product was that it was in use on the patient for monitoring as indicated.The leak came into contact with the patient or healthcare provider and at the time, it was identified that the normal saline used with the transducer set up was leaking so this could have affected the rn.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
The reported complaint of tubing separation was confirmed on the returned set.During visual inspection, the 19" pressure tubing was received separated from the female luer.When the tubing pocket was microscopically examined, insufficient adhesive coverage was observed on the tubing pocket.The probable cause of insufficient adhesive coverage on the pressure tubing had occurred due to an error during assembly in manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VALVES, 3ML FLU
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 19055404
• Report Number: 9617594-2024-00377
• Device Sequence Number: 6986290
• Product Code: DRS
• UDI-Device Identifier: 00887709098077
• UDI-Public: (01)00887709098077(17)250901(10)8035034
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• 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): 05/16/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2025
• Device Catalogue Number: 42800-35
• Device Lot Number: 8035034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: NORMAL SALINE, MFR UNK.
• Patient Sex: Unknown