MAUDE Adverse Event Report: CONCORD MANUFACTURING CRIT-LINE BLOOD CHAMBER

Catalog Number CL10021021

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment a blood leak occurred.The leak was visually observed.Estimated blood loss was 200cc's.Patient did not require any medical intervention.Sample is not available; sample was discarded.

Manufacturer Narrative

The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

• Brand Name: CRIT-LINE BLOOD CHAMBER
• Manufacturer (Section D): CONCORD MANUFACTURING; concord CA
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3969787
• MDR Text Key: 4606651
• Report Number: 2937457-2014-00779
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CL10021021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008K MACHINE
• Patient Age: 57 YR