MAUDE Adverse Event Report: IRVING MANUFACTURING PLANT NATURALYTE 1001 1K 0.0CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number 08-1001-0

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

Patient Problem No Code Available (3191)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between the hd treatment with the naturalyte 1001 1k 0.0ca 1mg jugs and the patient¿s hospitalization for hypocalcemia.However, currently there is no objective evidence that a naturalyte 1001 1k 0.0ca 1mg product deficiency or product label discrepancy was associated with this event.The facility administrator for the patient¿s associated clinic reported the user facility received an order of naturalyte 1001 1k 0.0ca 1mg jugs instead of naturalyte 1001 1k 2.5ca 1mg jugs.Hemodialysis is a form of renal replacement therapy for patients with renal failure which works mainly by the processes of diffusion (of toxins and electrolytes) and ultrafiltration (of water).Diffusion of electrolytes depends on the concentration gradient between the electrolyte in the patient ¿s blood and the electrolyte in the dialysate.The concentration gradient will affect whether an electrolyte will diffuse from the patient¿s blood (serum concentration is higher) or to the patient¿s blood (dialysate concentration higher) during treatment.In this reported case, patient hypocalcemia after the patient dialyzed with a 0.0 calcium dialysate is an expected finding.Diffusion of calcium from the patient¿s blood will occur because of the concentration of calcium being higher in the patient blood than the dialysate used (0.0) during a hemodialysis treatment.

Event Description

A hemodialysis (hd) user facility reported to fresenius customer service (cs) that they had previously received the wrong order of naturalyte product.Additionally, it was reported that a patient on hemodialysis (hd) therapy was hospitalized as a result.There were no reported allegations that the naturalyte delivered was defective.Additional information was obtained via follow-up with the clinic's facility administrator (fa).The fa confirmed the clinic received naturalyte 1001 1k 0.0ca 1mg jugs instead of naturalyte 1001 1k 2.5ca 1mg jugs.The fa stated the clinic used what was delivered on unknown date(s) for the patient, and the patient was subsequently hospitalized for hypocalcemia.Additional details surrounding the patient¿s hospitalization (such as calcium levels, treatment and discharge dates) and patient information (name, date of birth, and age) are unknown despite multiple due diligence attempts.At this time, no further information has been provided.

Manufacturer Narrative

Plant investigation: there were no reported allegations that the naturalyte delivered was defective, and no sample was returned to the manufacturer for evaluation.Additionally, no photographic evidence was provided to confirm the complaint.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

• Brand Name: NATURALYTE 1001 1K 0.0CA 1MG GAL
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): IRVING MANUFACTURING PLANT; director, quality systems; 5201 regent suite 100; irving TX 75063
• MDR Report Key: 10694480
• MDR Text Key: 211864327
• Report Number: 1651896-2020-00002
• Device Sequence Number: 1
• Product Code: KPO
• UDI-Device Identifier: 00840861101627
• UDI-Public: 00840861101627
• Combination Product (y/n): N
• PMA/PMN Number: K981043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 08-1001-0
• Device Catalogue Number: 08-1001-0
• Device Lot Number: 20HTAC022
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization