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 Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.Investigation is not yet complete.

Event Description

The event involved a transpac that the customer reported leaking at the transducer.The customer reported as the tubing was being used, it was noted that the blood backed up from the patient's umbilical arterial catheter to the transducer.The connections were checked and secure.The nurse performed a flush, and saw the tubing was still leaking.Tpn was attached to the stopcock, and then the microclave directly on the umbilical arterial catheter.There was a large amount of blood loss or bleed back reported, but the customer was unable to quantify.New tpn and new tubing primed.There was patient involvement, however, no adverse event, and no patient harm.

Manufacturer Narrative

H10: one used partial list # 426340405, transpac® iv monitoring kit neonatal, 12", 3 stopcocks, disposable transducer, 30 ml squeeze flush (for use with infusion pump); lot # unknown and one used alaris pump, filter set was received for evaluation.The reported complaint of leak was confirmed on the returned set.During visual inspection, a crack was observed on the squeeze flush device.No crazing was observed around the crack.The set was primed and pressure leak tested and a leak was observed from the crack of the squeeze flush device.The probable cause of the crack on the squeeze flush device was not determined.The device history review (dhr) review could not be completed since no lot number was provided.

• 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
• MDR Report Key: 10527437
• MDR Text Key: 206775567
• Report Number: 9617594-2020-00380
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TOTAL PARENTAL NUTRITION, MFR UNK.; TOTAL PARENTAL NUTRITION, MFR UNK