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 05/16/2015

Event Type  malfunction  

Event Description

A hemodialysis inpatient 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.Blood loss was negligible according to the nurse.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

Plant investigation has not yet been completed.A f/u 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
• 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: 4834474
• MDR Text Key: 20719815
• Report Number: 2937457-2015-01105
• 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,health professional,use
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

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
• Device Lot Number: 14111308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2015
• 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
• Removal/Correction Number: Z-1716-2015
• Patient Sequence Number: 1