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 Problem Death (1802)

Event Date 04/19/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Plant investigation is in process.A supplemental mdr will be submitted at the completion of this activity.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.Clinical review: although requested, medical records have not been received.Medical evaluation of the event with the information provided was performed by the fresenius medical department and is as follows: this patient initiated hemodialysis (hd) in hospital set up for the first time.No prior relevant history was available, other than use of concomitant altepase, which was administered soon after commencement of hd.Altepase is a tissue plasminogen activater therapy ( tpa) for treatment of embolic or thrombotic stroke, in this case, it was being used to improve catheter flow.Hd session was commenced for a total of half hour period and abruptly terminated, as patient was observed not to be stable.Soon after discontinuation of hd session the patient deceased.No machine anomalies were observed and the machine is back in service.Request for further relevant medical information was solicited, but denied.Limited information on this case precludes a meaningful medical assessment on this case.Review of this single individual case does not affect the benefit-risk assessment of our products used for hd.

Event Description

A nurse at the user facility reported that a patient expired shortly after their hemodialysis (hd) treatment was discontinued.Follow-up information was provided by the clinical manager (cm) who revealed that no device malfunctions occurred prior to the event.Reportedly, the patient had only recently been diagnosed with end stage renal disease, and this was the first time hd therapy had been applied.The treatment was performed in a hospital acute dialysis facility.The patient was alert, oriented, and ambulatory prior to treatment, but was noted as being ¿anxious.¿ treatment was paused 15 minutes after being initiated due to poor blood flow from the patient¿s catheter.Altepase was instilled in the catheter and allowed to dwell for 15 minutes.The medication was removed from the catheter and it was flushed prior to re-initiation of hemodialysis.Approximately 15 minutes later, the patient complained of not feeling well.The blood was returned, but the patient¿s heart rate began to decline.The patient lost consciousness and was without a pulse or respirations.The hospital code team was called and cardiopulmonary resuscitation (cpr) was initiated.An automated electrical defibrillator was placed, but no shock was advised.The rhythm was pulseless electrical activity.Cpr continued for approximately 40 minutes, but the patient was not able to be revived.No prior relevant history was available, other than use of concomitant altepase, which was administered soon after commencement of hd.Altepase is a tissue plasminogen activator (tpa) therapy for treatment of embolic or thrombotic stroke.Hd session was commenced for a total of half hour period and abruptly terminated, as patient was observed not to be stable.Soon after discontinuation of hd session the patient expired.The 2008t hemodialysis machine was removed from service after the event and evaluated by a fresenius regional equipment specialist (res).No malfunction or anomalies observed or identified.The unit was found to be working to specification.The machine has been returned to service at the user facility with no further issues.The fresenius bloodline is available for evaluation by the manufacturer.No sample of the acid in use during the treatment is available for analysis.

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation.A visual examination of the returned device found the arterial and venous lines to be acceptable.The venous and arterial patient end connectors were examined and no defects or obstructions were identified that could be attributed to ¿poor blood flow.¿ additionally, no kinks were present on the venous or arterial lines.The fresenius combi set bloodline device was then tested using a 2008t hemodialysis (hd) machine for simulated use.During the simulated use test, there were no observations of any obstructions or restrictions in the lines.Fluid flowed through the lines without issue.The arterial and venous pressures did not change and no alarms were generated during the 4 hour testing period.The device worked as intended with no abnormalities noted and no defects identified.A lot history review was performed of all fresenius combi set bloodlines from the reported catalog number (03-2722-9) 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 bloodline tubing sets 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 manufacturing review was not able to be performed.The investigation was not able to identify any device issues that could be associated with reported event.The evaluation of the complaint device confirmed that bloodline functioned fully as designed and met specification.Therefore, the complaint has been deemed unconfirmed.

• 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: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5664323
• MDR Text Key: 45440577
• Report Number: 8030665-2016-00237
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001107
• 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: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• 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: 10840861100293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2016
• 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): Death
• Patient Age: 66 YR