MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CRIT-LINE BLOOD CHAMBER; KOC

Catalog Number CL10021021

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/14/2015

Event Type  malfunction  

Event Description

A hemodialysis user facility has reported that during treatment a blood leak occurred.The leak was visually observed to be an external leak located at the threaded bottom end of the crit-line blood chamber that attaches to the dialyzer.The machine did not alarm.Estimated blood loss was minimal.The patient had no adverse effects and no medical intervention was required.The patient completed treatment.Sample is not available for manufacturing evaluation.

Manufacturer Narrative

The customer tightened the loose crit-line blood chamber and confirmed that the leak was resolved.The device was not returned to the mfr for physical evaluation, and the lot number was not able to be obtained to date; therefore an evaluation could not be performed.

• Brand Name: CRIT-LINE BLOOD CHAMBER
• Type of Device: KOC
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4834471
• MDR Text Key: 5912745
• Report Number: 2937457-2015-01109
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• 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: 05/13/2015
• 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