MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA OPTIFLUX F160NRE DIALYZER FINISHED ASSY.; DIALYZER, CAPILLARY, HOLLOW FIBER

Catalog Number 0500316E

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Air Embolism (1697)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The patient medical records were provided by the facility on january 11, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.There is no documentation within the medical record to suggest that the patient experienced an air embolism as a result of air in the combiset line.Additionally, there is no diagnosis of an air embolism within the provided documentation.The complainant indicated the device was not available for evaluation.Plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.

Event Description

A user facility reported a hemodialysis patient experienced an air embolism during their hemodialysis treatment.Reportedly, bubbles were noted in the line and treatment was stopped.The patient was treated at the clinic for a possible air embolism and taken to the hospital.The patient reported feeling "ill" prior to their treatment.The patient experienced blood loss of the whole circuit approximately 300cc.The patient was then transported via ambulance to the hospital.After being treated at the hospital, the patient was discharged home.The following day, the patient returned to the clinic and successfully completed their hemodialysis treatment.Upon examination of the bloodline, the user thought air might be coming into the line through a loose blue rubber port.On (b)(6) 2015 dialysis orders: dialyzer: 160nre optiflux.Dfr: autoflow 1.5.Dialysate composition: 3.0k, 2.5ca, 1.0mg, 100 dextrose.Sodium (meq/l): 137.Bicarbonate machine setting (meq/l): 34.Bfr: 450.Scheduled hours: 3.0.Blood volume processed: 81.0.Sodium modelling method: none.Estimated dry weight: (b)(6).On (b)(6) 2015 dialysis orders: dialyzer: 160nre optiflux.Dfr: autoflow 1.5.Dialysate composition: 3.0k, 2.5ca, 1.0mg, 100 dextrose.Sodium (meq/l): 137.Bicarbonate machine setting (meq/l): 34.Bfr: 450.Scheduled hours: 3.0.Blood volume processed: 81.0.Sodium modelling method: none.Estimated dry weight: (b)(6).

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius dialyzers from the reported catalog number (0500316e) shipped to this account within the selected time frame.A records review was performed on the seven lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.The patient's death cannot be confirmed in relation to the fresenius dialyzer.

• Brand Name: OPTIFLUX F160NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, CAPILLARY, HOLLOW FIBER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 475 west 13th street; ogden UT 43616
• Manufacturer (Section G): OGDEN PLANT; 475 west 13th street; ogden UT 43616
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5476717
• MDR Text Key: 39564853
• Report Number: 1713747-2016-00093
• Device Sequence Number: 1
• Product Code: FJI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0500316E
• Other Device ID Number: 00840861100149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 92 YR
• Patient Weight: 43