MAUDE Adverse Event Report: ICU MEDICAL TRANSPAC IV MONITORING KIT; PRESSURE TUBING

Model Number 46110-96

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problems Anemia (1706); Blood Loss (2597)

Event Date 06/19/2015

Event Type  malfunction  

Event Description

Arterial line tubing connection with catheter loosened and was leaking blood.Patient required a unit of blood for iatrogenic anemia.

• Brand Name: TRANSPAC IV MONITORING KIT
• Type of Device: PRESSURE TUBING
• Manufacturer (Section D): ICU MEDICAL; san clemente CA 92673
• MDR Report Key: 4895060
• MDR Text Key: 6066468
• Report Number: MW5043559
• Device Sequence Number: 1
• Product Code: DRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 46110-96
• Device Catalogue Number: 46110-96
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR