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

Catalog Number 03-2722-9

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

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 07/23/2016

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.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 from the reported catalog number 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.Clinical investigation: the patient medical records were provided by the facility on august 1, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.Based on the provided medical records along with details supplied by the complainant, a (b)(6) female end stage renal disease (esrd) patient began hemodialysis (hd) in the hospital after cardiac valve surgery and cardiogenic shock requiring extra corporeal membrane oxygenation (ecmo) on an unknown date.On (b)(6) 2016, the patient presented for her second regularly scheduled hd treatment at an outpatient facility.The patient¿s hd treatment was initiated at 11:10 am.Approximately 5 minutes after treatment initiation, the patient complained of chest pain and shortness of breath (sob).The patient has a significant medical history which included cardiac surgery, cardiogenic shock requiring ecmo, chronic kidney disease (ckd) - renal dialysis, diabetes mellitus type 2.Additionally, the patient has been residing in an acute care and skilled nursing facility for the past 3 months.There was no allegation that the patient¿s chest pain or shortness of breath was caused by any fresenius products.There is no documentation in the medical record that shows a causal relationship between the adverse health consequences of chest pain and shortness of breath experienced by the patient and the hd treatment that occurred on (b)(6) 2016.However, there is an association between the patient¿s chest pain and shortness of breath and the patient¿s medical history which likely attributed to the patient¿s medical condition which lead to the transfer of the patient to the emergency room (er) and subsequent admission into the hospital.

Event Description

A facility biomedical technician (bmt) telephoned technical support and reported a patient adverse event that occurred while a patient underwent a routinely scheduled hemodialysis (hd) treatment on (b)(6) 2016.This case concerns a (b)(6) female with a history of cardiac disease with recent cardiac valve surgery which required a three (3) month admission to both an acute and sub-acute hospital setting after complications arising from the cardiac surgery.The patient currently resides in a skilled nursing facility.No concomitant medications were disclosed.Hemodialysis (hd) treatments were initiated during the acute hospital period.On the date of the event, which was the patient's second hd treatment following their release, the patient arrived to the outpatient dialysis facility via wheelchair requiring a hoyer lift to the chair.The patient's pre-dialysis weight was recorded as 0.5 kilograms (kg) below their target dry weight.The patient was alert and oriented, and denied any discomfort prior to the treatments initiation.Ultrafiltration goal was set for 1.5kg.The hd treatment was initiated at 11:10 am.Approximately 5 minutes later, the patient complained of chest pain and shortness of breath.The blood within the extracorporeal circuit was returned and the treatment was ended.Oxygen (02) at 15l/min via facemask was initiated and emergency medical services (ems) was summoned.The patient remained alert with no further interventions performed.The patient was transported to the hospital, and admitted.The patient remains hospitalized, however, no further event details related to the patient's hospitalization have been provided.No diagnostic or audible alarms occurred during the brief treatment.The machine passed all pre-treatment testing.The machine was removed from service after this event and evaluated by the facility biomedical technician (bmt).No machine malfunctions were alleged, observed, or identified and the unit was returned to service at the user facility without issue.No malfunction of any other fresenius products in use during this hd treatment were alleged, observed, or identified prior to, during, or following the event.Per the clinic manager, a dialyzer reaction is not suspected as the patient had been dialyzing with this product type for "quite a while" without issue.The patient remains hospitalized and is scheduled to return to routinely scheduled hd treatments following their release.The 2008t hemodialysis (hd) machine is not available for evaluation.The dialyzer and bloodline are not available for evaluation by the manufacturer as both were discarded by the user facility.No samples of the acid/bicarb in use during the treatment are available for analysis.

• Brand Name: CUSTOM COMBI SET
• 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: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5896745
• MDR Text Key: 52778821
• Report Number: 8030665-2016-00434
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• 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: HEPARIN
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 126