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

Model Number 42648-06

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2018

Event Type  malfunction  

Manufacturer Narrative

One (1) used transpac iv monitoring kit was received and evaluated.A tubing separation was observed in the 3" arterial pressure tubing and the safeset port.The cause of the separation was insufficient solvent bond on the tubing.

Event Description

The customer reported the arterial line became disconnected at a junction point during patient use.It was reported that the monitor was able to sense an arterial line disconnection.There was a small amount of blood loss reported but no report of adverse event or delay in critical therapy.

Manufacturer Narrative

Subsequent to the initial medwatch, a user facility medwatch was received with additional information.

Event Description

The event occurred during blood pressure monitoring.

• Brand Name: TRANSPAC® IV MONITORING KIT
• Type of Device: TRANSPAC® IV MONITORING KIT
• 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: 7307640
• MDR Text Key: 101320194
• Report Number: 9617594-2018-00029
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619045012
• UDI-Public: 00840619045012
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

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: Nurse
• Device Model Number: 42648-06
• Device Catalogue Number: 42648-06
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 104