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 Problems Syncope (1610); Bradycardia (1751)

Event Date 08/19/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4) 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.The post market surveillance department is in the process of reviewing patient medical records and treatment sheets.The plant investigation is in process.A supplemental mdr will be submitted at the completion of these activities.

Event Description

The user facility medical records, which were provided for an unrelated event, stated that a patient with history of severe cardiomyopathy experienced a sudden unresponsive event while undergoing a hemodialysis treatment on (b)(6) 2014.On (b)(6) 2014, the patient was admitted to the hospital with a pre-syncope and bradycardia diagnosis.On (b)(6) 2014, while hospitalized, the patient underwent a hemodialysis treatment and experienced a secondary event of bradycardia, hypotension and unresponsiveness.Cardiopulmonary resuscitation (cpr) was performed and the patient was intubated.The patient recovered, but was no longer considered a candidate for hemodialysis due to severe cardiomyopathy and ejection fraction 10%.A peritoneal dialysis (pd) catheter was placed and the patient began pd on (b)(6) 2014.However, the patient has since returned to having hemodialysis treatments.The patient's current condition was noted as "doing well." no product information was made available.There are no allegations of device malfunctions having occurred.No complaint device is available for evaluation by the manufacturer.

Manufacturer Narrative

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 blood lines shipped to this account within the selected time frame.A records review was performed on the 15 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.Clinical investigation: the patient medical records were provided by the facility on march 11, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.The patient was admitted to the hospital on (b)(6) 2014.While undergoing hemodialysis (hd) treatment in the hospital on (b)(6) 2014, the patient experienced an event of bradycardia, hypotension, and unresponsiveness.At that time, the patient was found to no longer qualify to receive hd treatments.A peritoneal dialysis catheter was placed and the patient began peritoneal dialysis on (b)(6) 2014.There is no documentation in the medical record that indicates a causal relationship between the 2008k hemodialysis machine and the patient¿s pulseless electrical activity (pea) arrest.There is no documentation in the medical record that indicates a causal relationship between the fresenius dialyzer and the patient¿s pea.There is no documentation in the medical record that indicates a causal relationship between the fresenius bloodline and the patient¿s pea.The cause of the patient¿s pea arrest during the hemodialysis treatment was thought to be due to patient¿s inability to handle hemodialysis.The patient was switched to peritoneal dialysis without any further issues.There is no documentation in the medical record to indicate what hd products were used and which, if any, were fresenius products during the hd treatment performed on (b)(6) 2014.

• 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: 5510937
• MDR Text Key: 40689813
• Report Number: 8030665-2016-00131
• 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: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• 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: 04/12/2016
• 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; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 65