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

Model Number 011-0J729-01

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Device is expected to be returned to the manufacturer.It has not been received.

Event Description

The event involved a customer report of a single transpac it monitoring kit tubing set that disconnected from the pressure head.There was a report of patient blood loss but it was reported to be not clinically significant.The device was replaced and no further problems were encountered.It was reported that there was no delay in therapy and no adverse patient consequences.No additional information was provided.

Manufacturer Narrative

One (1) partial set 011-0j729-01, single transpac® it monitoring kit, unknown lot number was received for evaluation.The reported complaint of tubing separation was confirmed between the 92" red stripe arterial tubing and male luer.The bonding agent used was determined to be a standard cyclopentanone solvent.The solvent ring around the arterial tubing appears to be incomplete.Icu medical, through continuous initiatives has initiated a multitask team and reviewed the assembly process of this subassembly.

• Brand Name: TRANSPAC® IT MONITORING KIT
• Type of Device: TRANSPAC® IT 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: 7161540
• MDR Text Key: 96727810
• Report Number: 9617594-2018-00001
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011-0J729-01
• Device Catalogue Number: 011-0J729-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Patient Sequence Number: 1