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 05/13/2014

Event Type  malfunction  

Event Description

A clinical manager reported that approximately 2 hours into the patient's hemodialysis treatment, blood was noticed leaking "suddenly" leaking from the critline chamber where it connects to the dialyzer.She reported the camber looked "loose".The treatment was stopped.Only the blood from the arterial line was returned to the patient.Estimated blood loss 250ml which includes the venous line, dialyzer and some blood which had leaked on the floor.A new set of lines and dialyzer was set up and the treatment was completed.There was no patient adverse effect.No medical intervention was required.

Manufacturer Narrative

Based on the information provided, it is unknown how the device may have caused or contributed to the event.The plant investigation is pending.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; kaysville UT
• Manufacturer (Section G): HEMA METRICS; 695 north, 900 west; kaysville UT 84037
• Manufacturer Contact: tanya taft ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3987706
• MDR Text Key: 4891174
• Report Number: 2937457-2014-01017
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• 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: 14021201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: No
• 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 ACID AND BICARB CONCENTRATES; FRESENIUS SALINE; FRESENIUS BLOOD LINES; FRESENIUS DIALYSIS MACHINE; FRESENIUS DIALYZER
• Patient Age: 50 YR