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

Model Number 190713

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

Patient Problems Headache (1880); Pain (1994)

Event Date 05/30/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd treatment via the fresenius 2008t machine, fresenius granuflo acid bath, and fresenius bicarbonate solution and the patient¿s complaint of severe headache which resulted administration of tylenol, per patient standing orders, and an incomplete hd treatment.However, the patient did not require any further medical intervention for the event and no serious patient harm was reported.The patient reportedly resumed the next scheduled hd treatment without any issues.At this time, the exact cause of the event cannot be determined.Currently, there is no objective evidence contained in the file that indicates a malfunction or product issue with the products caused this event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a hemodialysis (hd) patient experienced a headache during their dialysis treatment on (b)(6) 2020 on a fresenius 2008t machine.A review of the patient¿s hd treatment sheet was performed.It was noted that the patient¿s dialysate composition utilized was the granuflo 2.0 potassium (k), 2.5 calcium (ca), 1.0 magnesium (mg) bath (lot number is unknown).Additionally, the dialysate utilized a 137 meq/l sodium without sodium modeling and 35 meq/l bicarbonate.Pre-treatment testing of the 2008t machine was conducted with no issues noted.Theoretic conductivity for the programmed dialysate bath was not recorded.The dialysate ph recorded was 7.0 and there was no presence of bleach.A review of all pre-treatment documentation indicates no unexpected findings.Patient pre-treatment vital signs recorded were within normal limits; blood pressure (bp) 115/57 sitting, pulse 80 regular, temperature 98.8 and respiratory rate (rr) 18.The patient¿s pre-treatment weight recorded (b)(6) kg and a target weight of (b)(6) kg (patient¿s dry weight is (b)(6) kg).There were no recorded patient complaints.At 12:25 pm the patient¿s treatment was initiated and at 13:01 it was recorded the patient began experiencing complaints of leg numbness and headache with a recorded bp of 144/82, pulse 59.It was documented the patient was placed on 2l oxygen via nasal cannula, received 200 cc normal saline, and machine ultrafiltration was turned off.The patient also received tylenol orally, per standing orders, as reported by the charge nurse during phone follow-up.At 13:30, the treatment was ended with administration of 300cc normal saline per patient request due to severe headache and leg pain unresolved with tylenol according to documentation on the treatment sheet.The patient¿s recorded bp was 143/89, pulse 57.Post dialysis vital signs recorded include bp 152/69 sitting, 150/64 standing, pulse 92 regular, rr 22, and temperature 97.4 with a post dialysis weight of 67.6 kg.Nursing assessment at 13:39 recorded the patient was alert and oriented, denied chest pain, hand grips equal bilaterally and speech appropriate.Vitals signs recorded bp 143/97, pulse 82, and oxygen saturation 97% on room air.The patient was discharged to home and the patient was advised to seek treatment at the emergency room if the headache did not resolve.The charge nurse reported the patient did not require any further medical intervention and did not require admittance to the er or hospital for the event.The patient resumed the next schedule hd treatment without any issues.Additionally, the charge nurse stated the products are not suspected to have caused the patient¿s headache.The machine was tested after the subsequent event to rule out machine malfunction.The nurse reported all functional checks passed.According to documentation on the form, the functional tests verified the conductivity and ph of the dialysate used at the time of the event were within parameters.Additionally, ultrafiltration controls using the settings prescribed for the patient during the event were functioning properly.It was reported the machine was returned to service post functional testing without any further issues or events.Furthermore, the bicarbonate mix and acid bath were found to be within specification and per the nurse, was not suspected to have caused the reported event.

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; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10370315
• MDR Text Key: 201844020
• Report Number: 2937457-2020-01402
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS GRANUFLO BICARBONATE; FRESENIUS NATRALYTE BICARBONATE
• Patient Outcome(s): Required Intervention
• Patient Weight: 65