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; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 42800-35

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2023

Event Type  malfunction  

Event Description

The event involved a transpac¿ it monitoring kit, 84" safeset reservoir, 2 needleless valves, 3ml flush device, macrodrip where it was reported that the the tubing that seats into the stopcock came loose without any force.Since arterial line transducer safeset is hooked up directly to the patient's artery via catheter blood was pouring from the failed stopcock.During the case when the anesthesiologist went to use the syringe to draw back for labs, he attached the syringe to the stopcock that is specifically used for drawing the sample.They clamped off the remaining tubing and spiked a whole new set and hooked it up to the patient.It was mentioned that, this is during a case in the or that needed an aline they hooked up the patient to the safeset and at the stopcock where the tubing connects came apart and it appears 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 involved and no human harm.

Manufacturer Narrative

The device is not available for investigation, however photos were provided.Investigation pending.

Manufacturer Narrative

The complaint of separation can be confirmed based on the photo provided.Received a photo showing the tubing separated from the rest of the assembly.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record for lot 13535292 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VALVES, 3ML
• 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: 17303327
• MDR Text Key: 319769136
• Report Number: 9617594-2023-00345
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709098077
• UDI-Public: (01)00887709098077(17)260201(10)13535292
• 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,Followup
• Report Date: 06/23/2023

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 Model Number: 42800-35
• Device Catalogue Number: 42800-35
• Device Lot Number: 13535292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: UNSPECIFIED CATHETER, MFR UNK