MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT, 152; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 01C-42640-06

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

Facility name: (b)(6).

Event Description

The customer reported a transpac iv monitoring kit was leaking.The event occurred approximately 1 hour into use during infusion of heparin saline while using a philips monitor for blood pressure monitoring.There was patient involvement, no adverse event, and no delay in critical therapy.Testing and investigation was able to confirm the complaint on the returned sample.The 3¿ pressure tubing was found separated from the male luer of the one-way stopper.The pressure tubing was tacky and not fully cured.When primed at gravity pressure and pressure leak tested, a leak was observed from the pressure tubing.The probable cause of the bond separation occurred during the assembly process at (b)(4).The device history review for lot number 3827412 was reviewed and there were no relevant non-conformances found.

• Brand Name: TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT, 152
• 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: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 9346434
• MDR Text Key: 195401836
• Report Number: 9617594-2019-00397
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619037475
• UDI-Public: (01)00840619037475(17)211001(10)3827412
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 01C-42640-06
• Device Lot Number: 3827412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• 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