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

Catalog Number CL10021021

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 04/22/2015

Event Type  malfunction  

Event Description

A hemodialysis user facility has reported that during treatment a blood leak occurred.The leak was visually observed at the connection of the crit-line blood chamber and the dialyzer.The crit-line blood chamber was tightened as soon the leak was visible.Tightening did not resolve the leak, and the crit-line was replaced with a different lot number of the same product.Estimated blood loss was less than 5 ml.The patient had no adverse effects and no medical intervention was required.The patient completed treatment.The sample has been discarded.Facility was unable to provide patient information.

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.A product recall has been initiated by the manufacturer and the reported product issue is being investigated by the manufacturer via a capa.

• Brand Name: CRIT-LINE BLOOD CHAMBER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; kaysville UT
• Manufacturer Contact: tanya taft, rn., cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4741792
• MDR Text Key: 5768364
• Report Number: 2937457-2015-00781
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• 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: 15011301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2015
• 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