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

Catalog Number CL10021021

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2014

Event Type  malfunction  

Event Description

A patient care technician reports devices were loosening during treatment which allowed a small amount of blood to leak.Upon follow up with the facility clinical manager she reports this facility has staff very experienced with the product and noted recently the occurrences of blood leaking from the area where the chamber connects to the dialyzer.The connection was tightened prior to the beginning of treatment and appears to loosen over time leading to a leak of blood.The devices were re-tightened during treatment and the treatments completed.Ebl <5ml.There were no patient adverse effects and no medical intervention was required.Patient identifiers are not available.The actual samples were discarded.Companion sample is available for return.

Manufacturer Narrative

The device was not returned to the manufacturer however, a companion sample from the same lot is available for return.Plant investigation is pending the receipt of the companion sample.A supplemental medwatch will be submitted upon the completion of the investigation.See related mdrs: 2937457-2014-01023, 2937457-2014-01024, 2937457-2014-01025, 2937457-2014-01026, 2937457-2014-01027, 2937457-2014-01028, 2937457-2014-01029, 2937457-2014-01030, 2937457-2014-01031, 2937457-2014-01032, 2937457-2014-01033 and 2937457-2014-01034.

• 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 st.; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3950821
• MDR Text Key: 4610314
• Report Number: 2937457-2014-01024
• 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: 05/16/2014

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: 131114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2014
• 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 DIALYZER; FRESENIUS SALINE; FRESENIUS ACID & BICARB PRODUCT; FRESENIUS DIALYSIS MACHINE; FRESENIUS COMBISET BLOODLINES