MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/SAFESET¿ 84" RED STRIPE ARTERIAL PRESSURE TUBING,; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46103-94

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, it has not been received.

Event Description

The event occurred on unknown date in (b)(6) 2019.The customer reported that a transpac iv monitoring kit w/safeset leaked at stopcock through which air can be drawn up.The mating device used at the time of the event is a catheter.There was patient involvement and blood loss, but no report of an adverse event, delay in critical therapy or need for medical intervention.It is not evident that the leak was associated with a life-threatening event or that an intervention was required to preclude permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

Date returned to mfg 9/13/2019.One used sample was returned for investigation.The reported problem of the leak was confirmed.The leak occurred from a cracked 1-way stopcock at the distal end of the safeset reservoir.The probable cause of the crack is due to an unintentional bending force across the safeset reservoir during use.The lot review was performed with no issues noted.

• Brand Name: TRANSPAC® IV MONITORING KIT W/SAFESET¿ 84" RED STRIPE ARTERIAL PRESSURE TUBING,
• 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; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8936432
• MDR Text Key: 198330559
• Report Number: 9617594-2019-00285
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619042639
• UDI-Public: (01)00840619042639(17)210701(10)3745919
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• 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: 08/07/2019

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: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 011-46103-94
• Device Lot Number: 3745919
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATHETER.