MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 0231 0K 2.25CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number 08-0231-4

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

Patient Problems High Blood Pressure/ Hypertension (1908); Vomiting (2144); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between naturalyte, and the patient¿s serious adverse events of depression, suicidal ideations, agitation, hypertension (admission diagnoses), and vomiting, esophagitis, and stomach ulcerations after the patient intentionally consumed naturalyte attempting to inflict self-harm.Failure to follow the products¿ instructions for use could result in the patients¿ injury or death.Based on the information available, naturalyte cannot be disassociated from the events.While the patient was not actively undergoing hd therapy when the events occurred, the patients¿ purposeful consumption of the product likely ¿indirectly¿ caused and/or contributed to the serious adverse events.Furthermore, follow-up information (e.G., treatment records, discharge summary) could not be obtained due to the nature of the complaint intake; therefore, preventing further review.However, there is no allegation or objective evidence indicating any fresenius product or device deficiency or malfunction occurred.Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

Fresenius became aware (via an article in the journal of the american society of nephrology) this patient with renal failure (rf) on hemodialysis (hd) for renal replacement therapy (rrt) was hospitalized (date not provided) due to depression and suicidal ideations.Further review of the article entitled ¿caustic injury after ingestion of naturalyte,¿ revealed the patient presented to the hospital with hypertension (235/142) and agitation.Hematological studies determined the patient¿s potassium was 3.7 mmol/l, and his bicarbonate was 25 mmol/l.The patient was admitted to the intensive care unit to undergo hd therapy, and during setting up, the patient intentionally ingested 100 ml of naturalyte to inflict self-harm.Immediately after ingesting the solution, the patient began to vomit.The patient was emergently placed on hd, and laboratory studies indicated his k+ = 4.1 mmol/l, ph (venous) = 7.4, and co2 = 20 mmol/l.Although the exact timeline is unknown, the patient underwent an esophagogastroduodenoscopy (egd) which revealed esophagitis and stomach ulceration.The patient was reportedly treated with pantoprazole and a subsequent egd indicated the patient was recovering.The article stated another instance of ingested naturalyte could not be found; therefore, the article proposed the patient was able to recover due to two main factors.The consumption of acidic solutions will often cause a patient to vomit, which in this instance limited absorption.The patient received hd shortly after ingesting the naturalyte; thereby averting any life-threatening events such as ¿multisystem organ failure.¿ due to the absence of additional information (e.G., patient demographics, primary outpatient dialysis clinic, treatment records, discharge summary), verbal and/or written follow up was not possible.

Event Description

Fresenius became aware (via an article in the journal of the american society of nephrology) this patient with renal failure (rf) on hemodialysis (hd) for renal replacement therapy (rrt) was hospitalized (date not provided) due to depression and suicidal ideations.Further review of the article entitled ¿caustic injury after ingestion of naturalyte,¿ revealed the patient presented to the hospital with hypertension (235/142) and agitation.Hematological studies determined the patient¿s potassium was 3.7 mmol/l, and his bicarbonate was 25 mmol/l.The patient was admitted to the intensive care unit to undergo hd therapy, and during setting up, the patient intentionally ingested 100 ml of naturalyte to inflict self-harm.Immediately after ingesting the solution, the patient began to vomit.The patient was emergently placed on hd, and laboratory studies indicated his k+ = 4.1 mmol/l, ph (venous) = 7.4, and co2 = 20 mmol/l.Although the exact timeline is unknown, the patient underwent an esophagogastroduodenoscopy (egd) which revealed esophagitis and stomach ulceration.The patient was reportedly treated with pantoprazole and a subsequent egd indicated the patient was recovering.The article stated another instance of ingested naturalyte could not be found; therefore, the article proposed the patient was able to recover due to two main factors.The consumption of acidic solutions will often cause a patient to vomit, which in this instance limited absorption.The patient received hd shortly after ingesting the naturalyte; thereby averting any life-threatening events such as ¿multisystem organ failure.¿ due to the absence of additional information (e.G., patient demographics, primary outpatient dialysis clinic, treatment records, discharge summary), verbal and/or written follow up was not possible.

Manufacturer Narrative

Correction: h6: investigation findings.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review could not be performed as required as the clinic number and lot number of the product remains unknown.Naturalyte liquid concentrate is acidic by nature and the product is not designed for parenteral use.The label warns customers that the product is not for parenteral use.It was also noted on the label that proper dilution is necessary before using the product.The dilution of the product at the time of ingestion is unknown.The product is to be administered to the patient only after meeting the conductivity and ph requirements at the clinic.Based on the investigation, the cause can be traced to intentional misuse by the patient during dialysis.There is no product allegation.

Event Description

Fresenius became aware (via an article in the journal of the american society of nephrology) this patient with renal failure (rf) on hemodialysis (hd) for renal replacement therapy (rrt) was hospitalized (date not provided) due to depression and suicidal ideations.Further review of the article entitled ¿caustic injury after ingestion of naturalyte,¿ revealed the patient presented to the hospital with hypertension (235/142) and agitation.Hematological studies determined the patient¿s potassium was 3.7 mmol/l, and his bicarbonate was 25 mmol/l.The patient was admitted to the intensive care unit to undergo hd therapy, and during setting up, the patient intentionally ingested 100 ml of naturalyte to inflict self-harm.Immediately after ingesting the solution, the patient began to vomit.The patient was emergently placed on hd, and laboratory studies indicated his k+ = 4.1 mmol/l, ph (venous) = 7.4, and co2 = 20 mmol/l.Although the exact timeline is unknown, the patient underwent an esophagogastroduodenoscopy (egd) which revealed esophagitis and stomach ulceration.The patient was reportedly treated with pantoprazole and a subsequent egd indicated the patient was recovering.The article stated another instance of ingested naturalyte could not be found; therefore, the article proposed the patient was able to recover due to two main factors.The consumption of acidic solutions will often cause a patient to vomit, which in this instance limited absorption.The patient received hd shortly after ingesting the naturalyte; thereby averting any life-threatening events such as ¿multisystem organ failure.¿ due to the absence of additional information (e.G., patient demographics, primary outpatient dialysis clinic, treatment records, discharge summary), verbal and/or written follow up was not possible.

• Brand Name: NATURALYTE 0231 0K 2.25CA 1MG GAL
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): OREGON MANUFACTURING PLANT; director, quality systems; 750 n lallendorf road; oregon OH 43616
• Manufacturer (Section G): OREGON MANUFACTURING PLANT; director, quality systems; 750 n lallendorf road; oregon OH 43616
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12934204
• MDR Text Key: 281751490
• Report Number: 3005162618-2021-00021
• Device Sequence Number: 1
• Product Code: KPO
• UDI-Device Identifier: 00840861101610
• UDI-Public: 00840861101610
• Combination Product (y/n): N
• PMA/PMN Number: K981043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08-0231-4
• Device Catalogue Number: 08-0231-4
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/23/2021
• 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): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male