MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 60" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 42800-27

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

It was reported that a transpac¿ it monitoring kit, 60" safeset reservoir, 2 blood sampling port, 3ml flush device, macrodrip squeeze flush mechanism appears ¿turned¿ and when the registered nurse (rn) tried to straighten it, it began leaking from the flush mechanism area.The product wa used for one hour.There was patient involved but no harm was reported.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Manufacturer Narrative

The reported complaint of leakage was not confirmed on the returned set.No visual anomalies were observed on the returned set.When the returned set was primed and pressure leak tested no leaks were observed near the flush mechanism.The set had performed per the specifications.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information in g1.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 60" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F
• 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: 17461109
• MDR Text Key: 320600185
• Report Number: 9617594-2023-00487
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709097995
• UDI-Public: (01)00887709097995(17)250901(10)9463108
• 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: 07/10/2023

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 Catalogue Number: 42800-27
• Device Lot Number: 9463108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• 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 FLUID, UKN MFR