MAUDE Adverse Event Report: HEMAMETRICS CR IT-LINE BLOOD CHAMBER

Model Number 00020034REVD

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

Patient Problems Exsanguination (1841); Loss of consciousness (2418)

Event Date 05/05/2015

Event Type  Injury  

Event Description

Arrived at pt's machine at 1400 (last vitals performed at 1344 by pct) and approx 500cc blood was on the floor and was shooting out of the top of the dialyzer where the crit-line sensor was connected.Pt 2 hour and 40 minutes into treatment.Staff reports that the tubing became loose from tho crit-line blood chamber adapter.

• Brand Name: CR IT-LINE BLOOD CHAMBER
• Type of Device: BLOOD CHAMBER
• Manufacturer (Section D): HEMAMETRICS; kaysville UT
• MDR Report Key: 4771844
• MDR Text Key: 5787610
• Report Number: 4771844
• Device Sequence Number: 1
• Product Code: FJK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Model Number: 00020034REVD
• Device Catalogue Number: 10021021
• Device Lot Number: 14111311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2015
• Distributor Facility Aware Date: 05/05/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR
• Patient Weight: 60