MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS DIALYZERS OGDEN; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device is not available for evaluation.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility reported that a blood leak occurred while a patient was undergoing a hemodialysis (hd) treatment.A few drops of blood were observed on the floor and was traced to the connection of the arterial line into the dialyzer.Reportedly, the arterial line was not fully secured into the dialyzer, which resulted in minimal patient blood loss.The connection was tightened, and then the treatment was continued and completed without further issue.No damage or irregularities were visible to the connectors of the bloodline or dialyzer.The patient's estimated blood loss was noted as being approximately 50ml.There were no adverse effects experienced by the patient and no medical intervention was required.The patient successfully completed treatment using the same circuit and hd machine after the connection was secured.The patient's hd treatment was performed using a fresenius 2008k hd machine along with a fresenius f160 dialyzer and a fresenius bloodline.Follow-up information was provided by a nurse at the user facility who revealed the following event information.No machine alarms were generated as there was no internal blood leak where blood and dialysate mixed.The blood leak was cleaned up after being identified.However, the following day, while the unit was being prepared for use, prior to a patient being connected, dark red specks were identified on the exterior locking area, the silver part, of the blue hansen.Blood test strips were used and tested positive for dried blood.The machine was rinsed 3 times, but some residual blood remained so the unit was pulled from the floor and then the head of the hansen was replaced by the on-site biomedical engineer.Functional testing performed by the biomed confirmed the unit was operating properly.The 2008k hd machine has been returned to service at the user facility without issue.The complaint devices are not available for return to the manufacturer for evaluation as both the dialyzer and bloodline were discarded by the user facility.

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.The customer reported that the incident had occurred with a f160 dialyzer type, but did not provide a lot number or catalog number.A lot history 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.No information was found and no lots were identified during this review, which sought to identify the lot numbers for all fresenius dialyzers shipped to this account within the selected time frame.As the lot number was not identified by the user facility and since no lot information was identified during the ship history, a second lot history review was performed to identify the last f160 dialyzer assembly shipped to this account.A manufacturing and records review was performed of the last dialyzer assembly, an e-beam sterilized dialyzer, found to have been delivered to this dialysis center.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 lot passed all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.However, follow-up information, provided by the complainant, confirmed that the incident was caused by the end user, as the bloodlines were found to be incorrectly seated, leading to an external leak.The connection was tightened into the luer lock and the patient completed treatment.Therefore, the complaint has been deemed as not confirmed.

• Brand Name: FRESENIUS DIALYZERS OGDEN
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 5729785
• MDR Text Key: 47841282
• Report Number: 1713747-2016-00414
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• 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