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 Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

Event Type  malfunction  

Event Description

The event involved a customer allegation regarding a transpac iv monitoring kit with safeset reservoir stating that during infusion the pressure line was disconnected/broken between the line and the blood withdrawn port.The device was replaced with no further problems encountered.There was patient involvement, however, there was no adverse event and no delay in critical therapy.The device was used with a phillips monitor for blood pressure monitoring and heparinized saline medication.

Manufacturer Narrative

Correction to the previously submitted report: a review of testing indicated one (1) used partial set 01c-42640-06 transpac® iv monitoring kit with safeset; lot# 3514084 was received.A tubing separation was observed in the 27" arterial pressure tubing and the safeset port.The cause of the separation was due to insufficient solvent.

Manufacturer Narrative

One (1) used transpac® iv monitoring kit with safeset list # 01c-42640-06, lot # 3514084 was received for testing.The set was received with a separation between the male luer tip of the safeset reservoir and female luer, which is a uv bonded connection.A dhr review was completed and no non conformances were noted.A separation occurred between the male luer tip of the safeset reservoir and female luer, which is a uv bonded connection.It appears that enough uv adhesive was applied at the bond and that the bond was separated due to excessive twisting force.

• 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
• MDR Report Key: 7743753
• MDR Text Key: 115908458
• Report Number: 9617594-2018-00045
• 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,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: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEPARINIZED SALINE; PHILLIPS MONITOR