MAUDE Adverse Event Report: ICU MEDICAL, INC TRANSPAC; TRANSDUCER

Catalog Number 42586-05

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Blood Loss (2597)

Event Date 03/25/2014

Event Type  malfunction  

Event Description

Baby had a peripheral arterial line in the left saphenous, which was being transduced and had 0.45 normal saline w/heparin 1unit/ml running through it at 1ml/hr.Blood draw was performed via arterial line.Art line flushed after blood draw.Nurse noticed no blood back into the line when nurse left the bedside to send the labs.<1min later nurse came back to the bedside, glanced in the baby's bed and saw blood back into the line and onto the chux that holds the transducer.Nurse immediately check all connections and found a loose connection to the distal port, next to the flush port.Once connections were tightened, chux was weighted and 2ml blood loss noted.Md was notified and no intervention was ordered.Nurse noted that they had to retighten the same connection on at least one other patient recently.

• Brand Name: TRANSPAC
• Type of Device: TRANSDUCER
• Manufacturer (Section D): ICU MEDICAL, INC; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 3752882
• MDR Text Key: 4484306
• Report Number: 3752882
• Device Sequence Number: 1
• Product Code: DRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 42586-05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DAY