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 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned to the manufacturer for investigation.It has not been received.Investigation is not complete.

Event Description

The event involved a transpac iv monitoring kit with safeset reservoir and blood sampling port that disconnected between the pressure line and the blood withdrawal port.The device was in use for approximately 1 hour with heparinized saline for blood pressure monitoring.The device was replaced with no further problems encountered.There was no adverse event or delay in critical therapy.

Manufacturer Narrative

Received one (1) used partial set 01c-42640-06 transpac iv monitoring kit with safeset, lot# 3514084 for testing.Testing found a tubing separation in the 27" arterial pressure tubing and the safeset port.There was sufficient solvent applied to the bond.A device history review (dhr) was completed and no non-conformances were noted.The reported complaint of tubing separation was confirmed.The cause of the separation appears to be due to excessive pulling force near the safeset port.

• 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
• MDR Report Key: 7743721
• MDR Text Key: 115905808
• Report Number: 9617594-2018-00044
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619037475
• UDI-Public: 840619037475
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• 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: 3514084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEPARINIZED SALINE