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

Model Number 01C-42640-06

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

One (1) partial set 01c-42640-06 transpac® iv monitoring kit with safeset¿ reservoir and blood sampling port, lot# 3550279 was received for evaluation.As received, a tubing separation was observed in the 3" arterial pressure tubing and the safeset port.The cause was insufficient solvent bond on the tubing.A dhr review of the monitoring kit, lot # 3550279 was completed and no non-conformities were noted.The reported complaint of tubing breakage or separation was confirmed.The cause of the separation was due to insufficient solvent.

Event Description

The event involved a customer allegation regarding a transpac iv monitoring kit with safeset reservoir and blood sampling port that during infusion, the pressure tube disconnected, causing blood reflux into the tube.The device was in use for approximately 1 - 2 hours with heparinized saline and phillips monitor for blood pressure monitoring.The device was replaced with no further problems encountered.There was no adverse event or delay in critical therapy.

• Brand Name: TRANSPAC IV MONITORING KIT WITH SAFESET RESERVOIR
• Type of Device: TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR
• 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: 7691200
• MDR Text Key: 114432423
• Report Number: 9617594-2018-00042
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• 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: 3550279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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