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; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number UNKNOWN

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2023

Event Type  malfunction  

Event Description

The event involved transpac¿ it monitoring kit, 84" safeset reservoir, 2 needleless valves, 3ml flush device, macrodrip which was reported to have separated/disconnected during patient use.The customer stated that during a procedure in the operating room that required an arterial line, they hooked the patient up to the safeset and they noticed that at the stopcock, where the tubing connects, it came apart and appeared that the tubing didn't have the proper epoxy/adhesive to adequately adhere to each other.As a result shortly after, it came apart with little resistance and it started bleeding back.There was patient involvement, but no harm was reported as a consequence of this event.

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.D1 - transpac¿ it monitoring kit, 84" safeset reservoir, 2 needleless valves, 3ml flush device, macrodrip.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VALVES
• Type of Device: 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17356122
• MDR Text Key: 319701872
• Report Number: 9617594-2023-00399
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SYRINGE, UNK MFR; UNSPECIFIED CATHETER, UNK MFR