MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IT MONITORING KIT W/SAFESET RESERVOIR, 03 ML FLUSH DEVICE, 84" RED ST; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46106-23

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return for evaluation.It has not been returned.

Event Description

The event involved a transpac® it monitoring kit w/safeset¿ reservoir, 03 ml flush device, 84" red stripe pressure tubing and 2 needleless valves that the pressure sensors did not work and there was a leak noted at the level of the syringe valve generating an air intake when flushing.The device was immediately replaced and the therapy resumed.There were no cracks or breaks noted on the product.There was 1 ml blood loss and a delay in therapy reported, but no medical interventions were required.No harm was reported.

Manufacturer Narrative

H10 - the reported complaint of pressure sensor did not work could not be confirmed.No samples, videos, pictures were returned for evaluation.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.A probable cause cannot be identified from the information provided.Additional information can be found in section d10.

• Brand Name: TRANSPAC IT MONITORING KIT W/SAFESET RESERVOIR, 03 ML FLUSH DEVICE, 84" RED ST
• 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: 9889415
• MDR Text Key: 219547859
• Report Number: 9617594-2020-00091
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619056438
• UDI-Public: (01)00840619056438(17)220901(10)4375034
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 011-46106-23
• Device Lot Number: 4375034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1