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

Catalog Number CL10021021

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 09/12/2014

Event Type  malfunction  

Event Description

A hemodialysis user facility has reported that during treatment a blood leak occurred.Crit-line backed out of dialyzer during treatment, became disconnected resulting in blood loss.Crit-line has been screwed in very tightly prior to treatment and was checked after blood was in it.After re-attaching it to dialyzer, it began leaking around it.The leak was visually observed on the arterial side of the dialyzer.Estimated blood loss was 200-300cc's.The pt had no adverse effects and did not require any medical intervention.Sample is not available; sample was discarded.

Manufacturer Narrative

The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

• Brand Name: CRIT-LINE BLOOD CHAMBER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): CONCORD PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451-1457 ; 8006621237
• MDR Report Key: 4185016
• MDR Text Key: 5025283
• Report Number: 2937457-2014-02906
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• 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: 14041307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2014
• 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
• Treatment: FRESENIUS 2008T MACHINE
• Patient Age: 83 YR