MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190713

Device Problem Fluid/Blood Leak (1250)

Patient Problems Syncope (1610); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Blurred Vision (2137); Vomiting (2144); Blood Loss (2597)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis sys and the patient¿s serious adverse event(s) of nausea, vomiting, blurred vision, fatigue, lightheadedness, hypotension and blood loss.The etiology of the hypotension is unknown; therefore, causality cannot be firmly established.However, intradialytic hypotension occurs in approximately 25% of all hd treatments, and is the most frequently observed complication of hd therapy.The patient¿s nausea, vomiting, blurred vision, fatigue and lightheadedness can reasonably be attributed to the underlying hypotension.The blood loss was caused from discontinuing treatment and initiating another.Based on the information available, the 2008t hemodialysis sys cannot be disassociated from the event(s) as there is insufficient evidence to exclude the 2008t hemodialysis sys from a causal or contributory role.Fresenius was not contacted to provide servicing, and no machine service/repair records were made available.As such, no assessment regarding the machine¿s functionality during the event(s) can be completed.Additionally, it is also unknown to what extent the leaking, tmp alarms and/or blood leak detected alarm contributed to the event(s).

Event Description

On (b)(4) 2019 fresenius was made aware this (b)(6) female patient with end stage renal disease (esrd) on hemodialysis (hd) thrice weekly for renal replacement therapy (rrt) experienced nausea, vomiting, blurred vision, fatigue, lightheadedness, hypotension and blood loss during hd therapy on (b)(6) 2019.During follow-up, the patient¿s registered nurse (rn) stated the clinic staff noticed the 2008t hemodialysis sys leaking unspecified fluid from the rear of the machine, accompanied by a transmembrane pressure (tmp) alarm.Subsequently the patient complained of nausea, blurred vision and lightheadedness.The patient was given 500ml of normal saline (ns) and was transferred to another hd machine to complete hd therapy.The rn reported a blood leak alarm occurred after the patient was disconnected from the 2008t hemodialysis sys.The patient lost approximately 100 ml of blood due to the event.Machine records and additional information was requested; however, the request was declined.The rn stated the optiflux 160 dialyzer and fresenius bloodlines were discarded following the event; however, there was no allegation of product malfunction against the dialyzer or bloodlines.The hd treatment record from (b)(6) 2019 was received by fresenius on 03/26/2019.The treatment record states, the patient arrived for their scheduled hd treatment in stable condition with no edema or pain.The patient¿s pre-treatment vital signs were: blood pressure (bp) = 150/75 (standing), bp = 154/73 (sitting), respiratory rate (rr) = 16, pulse (p) = 65.The patient¿s hd treatment was initiated at 6:04 am and remained uneventful until 8:03 am, when the patient¿s tmp alarm sounded.The patient was given 100ml of ns to clear out the venous chamber, and the patient¿s vital sign interval was set to 15 min.At 8:24 am the patient complained of nausea and lightheadedness, and upon review of the patient¿s bp, it was noted to be 69/47.The patient experienced a small emesis, after which she was placed in the trendelenburg position and given a combined total of 500ml of ns.At 8:28 am the patient¿s vital signs improved with the administration of ns and positioning changes.Bp = 187/85, p = 69.The record states the patient¿s blood was returned and she was transition to another hd machine, as the current 2008t hemodialysis sys was leaking and the tmp alarm was sounding (with no mention of a blood leak alarm).Following the event(s), the patient completed their 4.0-hour treatment without additional issue.Post-treatment the patient complained of feeling ¿groggy¿ and fatigued, however she ambulated without assistance and was discharged home.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8486635
• MDR Text Key: 141063787
• Report Number: 2937457-2019-01005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS BLOODLINES; FRESENIUS OPTIFLUX DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 62