MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IT

Model Number 011-0P247-01S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved a customer report of a single tanspac it transducer set that disconnected from the hub that was closest to the patient's arterial line.There was a report of patient blood loss but it was reported to be not clinically significant.The device was replaced.It was reported that there was no adverse patient consequences.No additional information was provided.

Manufacturer Narrative

One (1) used partial set transpac it was returned for evaluation.Testing found the 48" arterial tubing was separated from both the male and female luers.Solvent was present on both ends of the tubing, however, both appeared to have inadequate solvent.Icu medical, through continuous initiatives has initiated a multitask team and reviewed the assembly process of this subassembly.

• Brand Name: TRANSPAC® IT
• Type of Device: TRANSPAC® IT
• 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: 7176209
• MDR Text Key: 96775012
• Report Number: 9617594-2018-00003
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011-0P247-01S
• Device Catalogue Number: 011-0P247-01S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2018
• Patient Sequence Number: 1