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

Catalog Number CL10021021

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 04/15/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment, a blood leak occurred.At completion of treatment, as dialyzer flipped.The critline to dialyzer connection dislodged resulting in blood spraying on the neighboring pt who is fine and required to medical intervention.Estimated blood loss was 100-150cc's blood loss.The leak was visually observed at the arterial attachment where the critline screws into the dialyzer.

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 (Section G): CONCORD PLANT, FRESENIUS MED CARE NORTH AMERICA; 4040 nelson ave
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3911944
• MDR Text Key: 4495660
• Report Number: 2937457-2014-00802
• 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: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CL10021021
• Device Lot Number: 140101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; OPTIFLUX 160NR DIALYZER
• Patient Age: 35 YR
• Patient Weight: 63