MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT WITH SAFESET; TRANSPAC® IV MONITORING KIT WITH SAFESET¿

Model Number 01C-42640-06

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

One (1) used, partial set, list # 01c-42640-06, transpac® iv monitoring kit with safeset¿ reservoir ws received for testing.Testing found the 27" arterial pressure tubing separated from safeset port.The cause of the arterial tubing separation from the safeset port was insufficient solvent.A device history review (dhr) was completed and no relevant non-conformities were noted.The reported complaint of tubing separation was confirmed.The probable cause of the separation was due to insufficient solvent.

Event Description

The event occurred between (b)(6) 2018.It was reported that a transpac tubing set was disconnected/broken between the pressure line and the blood withdrawal port during infusion with heparinized saline after approximately 1 hour of use.The device as replaced with no further problems reported.There was no adverse event or delay in critical therapy reported.

• Brand Name: TRANSPAC IV MONITORING KIT WITH SAFESET
• Type of Device: TRANSPAC® IV MONITORING KIT WITH SAFESET¿
• 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: christopher zanoni ; 600 n. field drive, bldg h2-2n; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 7659288
• MDR Text Key: 113256483
• Report Number: 9617594-2018-00039
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619037475
• UDI-Public: 840619037475
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061573
• 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: 06/07/2018

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: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 01C-42640-06
• Device Catalogue Number: 01C-42640-06
• Device Lot Number: 3514084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1