MAUDE Adverse Event Report: CORPORATE COLLECTIVE CONCENTRATE- NATURALYTE; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number UNKNOWN-CONCENTRATE-NATURALYTE

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

Patient Problem Myocardial Infarction (1969)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: it is unknown if a temporal relationship exists between hd therapy utilizing collective concentrate ¿ naturalyte, collective concentrate ¿ granuflo and the patient reported serious adverse events of multiple myocardial infarctions.The etiology of the events is unknown; therefore, causality cannot be established.The incidence of acute coronary event(s), specifically myocardial infarctions in the end-stage renal disease (esrd) population are considerably higher than the general population.Based on the information available, the collective concentrates naturalyte and granuflo cannot be disassociated from the events.While there is no objective evidence indicating a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the events.The lack of detailed information, treatment records, samples for evaluation and discharge summaries prevents the collective concentrates from being excluded as having a possible causal or contributory role in the events.Plant investigation: a review of the file was performed and it was determined that there were no lot numbers, product codes, clinic or patient identifiers, or a specific timeframe recorded.Due to the lack of information present, a full investigation cannot be performed.

Event Description

A (b)(6) social media user reported experiencing experienced three heart attacks (myocardial infarctions) in the last ten years (two from atrial fibrillation, and one from ventricular fibrillation).Due to the lack of additional information, verbal and/or written correspondence was not possible.

• Brand Name: COLLECTIVE CONCENTRATE- NATURALYTE
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): CORPORATE; 920 winter street; waltham MA 02451
• Manufacturer (Section G): CORPORATE; 920 winter street; waltham MA 02451
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 10023939
• MDR Text Key: 189840321
• Report Number: 1225714-2020-00019
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• PMA/PMN Number: K981043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN-CONCENTRATE-NATURALYTE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/07/2020
• 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): Other