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

Catalog Number CL 10021021

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 04/30/2015

Event Type  Injury  

Event Description

A hemodialysis user facility has reported that during treatment a blood leak occurred.The leak was visually observed to be an external leak located at the threaded bottom end of the crit-line chamber that attaches to the dialyzer.The machine did not alarm.Estimate blood loss was 450ccs.The patient's hemoglobin levels dropped from 10g/dl to 8g/dl.The patient was given 2l iv of fluid and sent to the hospital.The sample was not available for evaluation.Medical records have been requested.

Manufacturer Narrative

Plant 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 METRIC DIVISION; 695 n 900 w; kaysville UT 84037
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4777076
• MDR Text Key: 5949819
• Report Number: 2937457-2015-00903
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CL 10021021
• Device Lot Number: 15011309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 71