MAUDE Adverse Event Report: ICU MEDICAL 3 WAY STOPCOCK

Model Number PM10-2777

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 07/28/2016

Event Type  malfunction  

Event Description

Pt leaking blood out of his umbilical arterial catheter between the first and second stopcock on the transducer.Estimated blood loss of 5ml.Catheter was clamped with fingers between the insertion site and the introducer to prevent any more blood loss.The first two stopcocks on the transducer were replaced.Once disconnected with the pt, there was a crack noticed between the first and second stopcock on the transducer, where blood was leaking out.Pt was stable throughout event, and monitored closely afterwards.Nnp and dr were notified and assessed pt.Orders were put in for one dose of vancomycin and to discontinued the umbilical arterial catheter.

• Brand Name: 3 WAY STOPCOCK
• Type of Device: STOPCOCK
• Manufacturer (Section D): ICU MEDICAL; san clemente CA 92673
• MDR Report Key: 5875202
• MDR Text Key: 52210296
• Report Number: MW5064071
• Device Sequence Number: 1
• Product Code: LHI
• 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: 08/10/2016

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 Expiration Date: 02/28/2019
• Device Model Number: PM10-2777
• Device Catalogue Number: 42383-01
• Device Lot Number: 3195717
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 DA
• Patient Weight: 3