MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 3; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 426340405

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

It is unknown if device is available for evaluation, if additional information is received, a supplemental report will be submitted.

Event Description

The customer reported an issue with transpac® iv monitoring kit neonatal, 12", 3 stopcocks, disposable transducer, 30 ml squeeze flush.The arterial line transducer primed and when connected to infant it was leaking and line came completely disconnected at a junction that is not a point of entry.It was further stated that the line was leaking and blood from the artery was bleeding back.There was patient involvement but no report of an adverse event or delay in therapy.

• Brand Name: TRANSPAC IV MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 3
• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 11983042
• MDR Text Key: 255809517
• Report Number: 9617594-2021-00175
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2021

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 Catalogue Number: 426340405
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1