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

Catalog Number CL10021021

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

A clinic reported a blood leak from a crit-line blood chamber.The leak was visually observed at the connection of the crit-line blood chamber and the dialyzer.The pt experienced no adverse effects and no medical intervention was necessary.Treatment was successfully completed.Estimated blood loss was reported as 20 - 50 ml.Leak occurred one to two hours into treatment.The device has been discarded by the user facility, but a companion sample from the same lot has been requested for investigation.

Manufacturer Narrative

The device was not returned to the mfr for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted 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; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street ; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4741818
• MDR Text Key: 5825397
• Report Number: 2937457-2015-00774
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/07/2015

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: 14121304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• 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
• Patient Age: 79 YR
• Patient Weight: 63