MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH AND MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 46106-91

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation.Testing is not complete.

Event Description

The event involved a transpac iv monitoring kit where air bubbles were found during set up, prior to connecting to a patient.The line was primed as per their normal practice with saline, which was still connected to the kit, but on final inspection, the nurse found that there were persistently forming bubbles at the electronic portion of the transducer.The air bubbles were attempted to flush out, but the bubbles were somehow coming into the system between the two stopcocks by the transducer itself.There was no patient involvement, there was no adverse event and no delay in therapy.

Manufacturer Narrative

One used list# 46106-91, transpac® iv monitoring kit w/03 ml squeeze flush and macrodrip, lot# unknown and one used 0.9% sodium chloride bag 250ml, manufacturer baxter was received for evaluation.The reported complaint of leakage or air in the line of the monitoring kit could not be confirmed.The kit was hydrostatically pressure leak tested and was determined to meet product specifications.Further, the returned sample was not observed to have air enter into the line during testing.No device history review (dhr) was conducted since no lot number was identified.

• Brand Name: TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH AND MACRODRIP
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8900744
• MDR Text Key: 198518535
• Report Number: 9617594-2019-00276
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46106-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2019
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1