MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IT; BIFURCATED MONITORING KIT W/03 ML FLUSH DEVICE, TRANSPAC® IT

Model Number 011-46110-48

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

There were no devices returned for testing and investigation; therefore, the complaint could not be confirmed.A device history record (dhr) review was completed and 2 relevant non conformities were noted.A 100% functional testing was done on the lot, including pull testing to 6 pounds and a movement and flexion test.All non-conforming pieces were discarded.Icu medical, through continuous initiatives has initiated a multitask team and reviewed the assembly process of this subassembly.

Event Description

The events occurred on unspecified dates in (b)(6) 2018.The customer reported the arterial tubing, before the three way stopcock, is detaching from the secure connectors on an unspecified number of bifurcated monitoring kits resulting in leaks.The events occurred in the intensive therapy unit or operating theatre.The customer reported that there was minimal blood leakage as a result of the leak and the patients' blood pressure remained stable.There was no reported delay of critical therapy and no medical interventions required.There were no adverse operator consequences reported.The devices were changed out with no further problems encountered.

• Brand Name: TRANSPAC® IT
• Type of Device: BIFURCATED MONITORING KIT W/03 ML FLUSH DEVICE, TRANSPAC® IT
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• Manufacturer (Section G): ICU MEDICAL, INC.; 600 n. field drive, bldg h2-2n; lake forest IL 60045
• Manufacturer Contact: regina rose ; 600 n. field drive, bldg h2-2n; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 7259820
• MDR Text Key: 99930930
• Report Number: 9617594-2018-00021
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: MT
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/01/2020
• Device Model Number: 011-46110-48
• Device Catalogue Number: 011-46110-48
• Device Lot Number: 3509535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1