MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IT; TRANSPAC® IT, 2 LINES, 2 TRANSDUCER, 60" (152 CM), 3 ML/HR FLUSH DEVICE, MACRODR

Model Number 011-0P247-01S

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

One (1) used partial set transpac® it, 2 lines, 2 transducer, 60" (152 cm), 03 ml/hr flush device, macrodrip was received and tested.The set was primed and pressure tested and a slow channel leak was observed at the uv bonded connection of the 12" red striped arterial tubing and the female luer.The bond was observed under a 10x microscope and a channel leak was observed due to insufficient uv adhesive.

Event Description

The customer reported that the transducer of the transpac it was leaking at the site of the 3-way stopcock.It was reported that the device was in use for one hour and that all connections were tightened and checked prior to use.The device was changed out with no further problems encountered.There were no reported adverse patient effects, no medical intervention required and no reported delay of critical therapy.

• Brand Name: TRANSPAC® IT
• Type of Device: TRANSPAC® IT, 2 LINES, 2 TRANSDUCER, 60" (152 CM), 3 ML/HR FLUSH DEVICE, MACRODR
• 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.; 951 calle amanecer; san clemente CA 92673
• Manufacturer Contact: regina rose ; 600 n. field drive, bldg h2-2n; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 7297620
• MDR Text Key: 101151328
• Report Number: 9617594-2018-00028
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011-0P247-01S
• Device Catalogue Number: 011-0P247-01S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1