MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IT MONITORING KIT, 60" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 42800-27

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Investigation is pending.

Event Description

The event involved a transpac iv disposable transducer where the arterial line came apart on line, not at a connection site during use.It was unknown on how long into the infusion the tubing separation/disconnection occurred.A new arterial line was set up and connected to patient.There was patient involvement but no harm was reported.

Manufacturer Narrative

H10 - one used transpac iv kit list# unknown, lot # unknown was received for evaluation.The reported complaint of fell apart during use was confirmed on the returned set.Three images were provided by customer, showing the involved product in a bag.During visual inspections, the 3" pressure tubing was found separated from the safeset port.The tubing pocket was microscopically examined and insufficient solvent was observed on the pressure tubing.The probable cause of the separation of the pressure tubing had occurred due to insufficient solvent applied during assembly process.A device history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TRANSPAC IT MONITORING KIT, 60" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F
• 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: 10824207
• MDR Text Key: 216132040
• Report Number: 9617594-2020-00483
• 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,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42800-27
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1