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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 09/06/2018

Event Type  Death  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation summary: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis machine and the adverse event(s) of blood loss, loss of consciousness, cardiac arrest and subsequent expiration of the patient.Causality for the event(s) is attributed to the patient¿s venous needle dislodgement, which was the likely cause of the patient¿s loss of consciousness, cardiac arrest and subsequent expiration.Based on the information available, there is no documentation or evidence the 2008t hemodialysis machine caused or contributed to a serious adverse event.The 2008t hemodialysis machine can be disassociated from the event(s) as there no allegation or evidence of the 2008t hemodialysis machine malfunctioning or failing to perform as expected in relation to the event(s).This is further evidenced by the negative findings when functional compliance testing was performed on (b)(6) 2018.

Event Description

On (b)(6) 2018, a user facility reported (via an fda form 3500a) a (b)(6) male patient with end stage renal disease (esrd) on hemodialysis (hd) thrice weekly for renal replacement therapy (rrt) for approximately 19 years, was found unconscious during hd therapy on (b)(6) 2018.The patient¿s past medical history includes polycystic kidney disease (pkd), congestive heart failure (chf), and atherosclerotic cardiovascular disease (ascvd).The medwatch form revealed the patient¿s venous fistula needle (not a fresenius product) dislodged, and the patient sustained blood loss of approximately 1.5 liters.Resuscitative measures were initiated at the user facility, and the patient was transferred to the hospital, where he expired approximately 1 hour after finding the patient unconscious.Information was obtained from the medwatch form 3500a, hd treatment records, and follow-up with the patient¿s hemodialysis registered nurse (hdrn).On (b)(6) 2018 at 17:07 (2.0 hours into a 3.0 hour hd treatment), the patient was found unresponsive.The last recorded vital signs were obtained at 16:55, and showed a blood pressure (bp) of 119/66 and a heart rate (hr) of 85.While attempting to administer normal saline (ns), it was noted the venous needle (not a fresenius product) was dislodged.The form states the patient lost approximately 1.5 liters of blood.Pressure was applied to the needle site, and ns was administered through the arterial line.911 was called, cardiopulmonary resuscitation (cpr) was initiated, and an automated external defibrillator (aed) was applied to the patient (advised no shock).The patient was given a total of 3.0 liters of ns at the user facility during the event(s).The patient remained unresponsive when emergency medical services (ems) transported the patient to the hospital, where he subsequently expired at 18:12.Post event, it was noted the paper tape and gauze dressing were still intact and attached to the needle; however these product(s) were not retained for further evaluation.During follow-up on (b)(6) 2018, the patient¿s hemodialysis registered nurse (hdrn) confirmed the patient ¿coded¿ during hd therapy on (b)(6) 2018 at 17:07.The hdrn also confirmed the patient was transferred to the hospital, where the patient was pronounced dead.Reportedly the cause of death was cardiac arrest; however no esrd death notification was available.The hdrn agreed to send the hd treatment record from (b)(6) 2018, as well as the functional compliance testing results for the 2008t hemodialysis machine post event.Further information was requested, however no additional information was provided.The records received included the hd treatment record from (b)(6) 2018 which revealed a stable hd treatment until the discovery of the patient¿s unconsciousness at 17:07.The treatment record indicates all pre-treatment machine safety checks were completed and were within normal limits.Additionally, there were no machine alarms noted in the treatment record.Functional compliance testing of the 2008t hemodialysis machine was performed on (b)(6) 2018, which noted no non-conformances.The patient¿s surgical history includes an angioplasty on (b)(6) 2018, and a right upper extremity arteriovenous fistula placement on (b)(6) 2010.The patient¿s medications were listed as hectorol 5 mcg ivp and flu vaccine 0.5 ml im, aspirin 81mg po.Lab rationale: hematologic studies upon admission to hospital on (b)(6) 2018: hgb = 4.71 g/100 ml, hct = 14.0 %, k+ = 5.1mmol/l, cl = 107 meq/l.For reference, critline monitoring from (b)(6) 2018: hgb = 9.7 g/100 ml, hct = 30.7 %.Hd orders: dialyzer = optiflux 180nre, dialysate flow = 800 ml/min, treatment time = 3.0 hours, blood flow = 500 ml/min, sodium = 140 meq/l, bicarbonate = 29 meq/l, potassium = 2.0 meq/l, calcium = 2.5 meq/l, magnesium = 1.0 meq/l, dextrose = 100 meq/l, 15 gauge needles (button hole method), heparin free.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.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.It was later confirmed that a fresenius technician inspected the machine, who confirmed the machine passed all functional test without issue.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
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7967373
• MDR Text Key: 123795037
• Report Number: 2937457-2018-03076
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 33