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

The device is expected to be returned for investigation.It has not been received.

Event Description

The event occurred on an unspecified date in (b)(6) 2018.The customer reported the arterial tubing, before the three way stopcock, is detaching from the secure connector of the bifurcated monitoring kit resulting in a leak.The event 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 patient's 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 device was changed out with no further problems encountered.

Manufacturer Narrative

One (1) used non-icu medical unspecified extension set was received.The complaint could not be confirmed as the device received was not an icu medical product.Subsequent to the initial medwatch report, manufacturing site was updated to reflect the legal manufacturing address instead of the address of the contact office.

• 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 ; 951 calle amanecer; san clemente, CA 92673 ; 2247062300
• MDR Report Key: 7235453
• MDR Text Key: 99048644
• Report Number: 9617594-2018-00010
• 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,Followup
• Report Date: 02/26/2018

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: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 02/21/2018
• Supplement Dates FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1