MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ICP KIT FOR YALE-NEW HAVEN HOSP.; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 460690433

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

The event involved a icp kit for yale-new haven hosp where the customer reported that the external ventricular drains (evd) noted to be leaking to bed linen.Neurosurgery notified to assess and change evd catheter.The patient has an anterior and posterior evd.The patient was on 7-3 neuro floor during the day and noted to have no drainage from anterior evd.Anterior evd was manipulated and changed.The patient was a renal replacement therapy (rrt) to pediatric intensive care unit (picu) after manipulation for q1hr neuro checks and evd management.The reporter observed that there was a small amount of drainage on the bed distal to the insertion site and proximal to the drainage chamber near the first 3-way stopcock.The reporter placed a paper chuck pad down to assess if the evd continued to drain into the linen.The resident then contacted neurosurgery and neurosurgery assessed at bedside.It was further stated that the reporter replaced the white paper chuck, but it was noted that the new white paper chuck was wet and assessed the evd catheter site closer.There was a cut/alteration to the catheter above the stop cock.The reporter then clamped the catheter with green kelly clamps.At 0000, it was noted that the evd was draining appropriately to the chamber.The case was done in npor.There were no charges for the external drain on there nor the icp kit.There was patient involvement; no harm was reported as a consequence of this event.

Manufacturer Narrative

The device has been received for evaluation, however, investigation is not yet complete.

• Brand Name: ICP KIT FOR YALE-NEW HAVEN HOSP.
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18970436
• MDR Text Key: 338714495
• Report Number: 9617594-2024-00336
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061573
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 460690433
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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: ARES IMPREGNATED CATHETER 146098; DELTA 1.5 46823