MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 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 04/29/2015

Event Type  malfunction  

Event Description

A clinic reported a blood leak from a crit-line blood chamber.The leak was visually observed coming from the crit-line blood chamber.The patient experienced no adverse effects and no medical intervention was necessary.Treatment was successfully completed.Estimated blood loss was reported as approximately 10 ml.The device has been discarded by the user facility.

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

• Brand Name: CRIT-LINE BLOOD CHAMBER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4834522
• MDR Text Key: 18257293
• Report Number: 2937457-2015-01091
• 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: Nurse
• Remedial Action: Recall
• 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
• Removal/Correction Number: FA-2015-6
• Patient Sequence Number: 1