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 05/08/2015

Event Type  malfunction  

Event Description

A hemodialysis user facility has reported that during treatment a blood leak occurred at the bottom connection of the crit-line blood chamber that threads to the dialyzer.The leak was visually observed to be an external leak below the wings of the pvc adapter around the threaded area that connects to the dialyzer.Estimated blood loss was no more than 30cc.The patient had no adverse effects and no medical intervention was required.The patient completed treatment.Sample has not been returned to mfr for eval.

Manufacturer Narrative

Plan investigation has not yet been completed.A follow up 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
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; kaysville UT
• Manufacturer (Section G): HEMA METRICS DIVISION; 695 n 900 w; kaysville UT 84037
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999751
• MDR Report Key: 4855535
• MDR Text Key: 19433477
• Report Number: 2937457-2015-01195
• 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,company representati
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• 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: 15011304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• 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