MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FMC BLOODLINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypervolemia (2664)

Event Date 05/27/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4) according to follow up with the registered nurse (rn), this event was not as a result of a product issue.It is a patient issue.The rn reported the patient cannot remove more than 2.5kg per treatment without experiencing severe cramping.As a result, the patient asks to stop additional fluid removal so does not remove all her fluid during treatment.This fluid which is not removed is added to between treatments via the patient¿s fluid intake.When this happens, they have to try to remove more fluid during the next treatment which leads to cramping and the same scenario for subsequent treatments.According to the rn, the patient has experienced cramping and other symptoms such as: shortness of breath due to this issue.The device was not available for investigation nor was the lot number known.The post market surveillance department is in the process of reviewing medical records and the plant investigation is in progress.A supplemental mdr will be submitted with additional relevant information.This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.

Event Description

During medical record review for an unrelated event, it was learned the patient experienced shortness of breath and fever of 100.4 during her hemodialysis treatment.The patient was discharged after her treatment and went to the emergency room.The patient was admitted to the hospital (b)(6) 2014 and discharged on (b)(6) 2014.The patient received a hemodialysis treatment during the admission; however, she remained afebrile with no elevation in white blood cells counts during this hospitalization.According to medical records, the patient developed a temperature of 100.4(f) after treatment.One set of blood cultures was drawn on (b)(6) 2014.The patient stated she would be going to the emergency room after treatment.On (b)(6) 2014 the blood culture results revealed no aerobic or anaerobic growth after 5 days incubation.There was no allegation of device malfunction associated with this event.Catalog/lot/sample not available.

Manufacturer Narrative

Clinical investigation: the patient medical records were provided by the facility on february 11, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.Patient is a (b)(6)-year-old female who received hemodialysis on (b)(6) 2014.The patient¿s post treatment temperature was 100.4.The patient complained of chills and refused tylenol.Blood cultures were ordered, but only one set of blood cultures was drawn.Patient indicated that the abdominal incision was mostly proximate; however; a small area (approximately 1.0cm) was open with yellow slough.The patient reported that after speaking with her surgeon, the decision was made to meet at the emergency room after the hemodialysis treatment is completed.The patient presented to the hospital with dyspnea and was found to have fluid volume overload upon examination.The patient was also found to have accelerated hypertension.Following an extra run of dialysis with volume taken off, the patient¿s blood pressure improved and patient was saturating well on room air.The patient also remained afebrile and had normal white blood cell counts during hospitalization.The cultures drawn in dialysis were negative and patient was not started on antibiotics.The patient was discharged from the hospital on (b)(6) 2014.Medical records support staff attempted to challenge patient to remove fluid below estimated dry weight at times, without success.Medical records do not contain hemodialysis treatment sheets for this event.Medical records reveal no infectious process occurred.Medical records reveal patient was in fluid overload following hemodialysis treatment.No malfunction was reported.There is no documentation in the medical record that indicates a causal relationship between the 2008k machine and the patient¿s fluid overload.There is no documentation in the medical record that indicates there is a causal relationship between the fmc bloodlines and the patient¿s fluid overload.There is no documentation in the medical record that indicates a causal relationship between the dialyzer and the patient¿s fluid overload.There is no documentation in the medical record that indicates a causal relationship between the concentrates and the patient¿s fluid overload.Medical records indicate patient was dialyzed, and then developed a fever of unknown origin not related to the hemodialysis treatment.The fever was not treated.Medical records reveal the patient is not always aggressively dialyzed to get patient below estimated dry weight (edw).Manufacturing investigation: 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 bloodlines shipped to this account within the selected time frame.A records review was performed on all 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.Therefore, the reported complaint cannot be confirmed in relation to the fresenius bloodline.

• Brand Name: FMC BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5489702
• MDR Text Key: 40000526
• Report Number: 8030665-2016-00112
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2016
• 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: 57 YR
• Patient Weight: 66