MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIQUID BICARBONATE 4000 FMC 3 BOT/CS; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number 08-4000-LB

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problems Anemia (1706); Sepsis (2067)

Event Date 11/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing investigation: the reported complaint is not confirmed as the complaint sample was not available for manufacturer evaluation, and the lot number of the suspect product was not provided.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.A lot history review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.No information was found and no lots were identified during this review, which sought to identify the lot numbers for all naturalyte liquid sodium bicarbonate product shipped to this account within the selected time frame.As the lot number was not identified by the user facility and since no lot information was identified during the ship history, a manufacturing review was not able to be performed.Clinical investigation: the patient medical records were provided by the facility on july 13, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.The patient medical records reveal that the patient was hospitalized the prior month for an infected arteriovenous (av) fistula.At that time, a temporary hemodialysis (hd) catheter was inserted and then changed over to a permacath.A call was placed to the clinic registered nurse (rn).The rn stated that the patient had claimed to have ripped his skin on the access site via a band aid removal.Per the rn, the patient did not want to go to the doctor and did not follow medical advice as to how to take care of the scab.According to the rn, 2 months later, an infection took place on (b)(6) 2015.The rn states the patient was hospitalized later that day, and diagnosed with (b)(6).Medical records do not contain complete culture results.The rn stated that the patient received recalled lots of naturalyte liquid sodium bicarbonate product in 2015.However, the rn also stated that fresenius products were not related to the infection as the organism detected was not listed in the recall.It should be noted that the organism related to the recalled 08-4000-lb bicarbonate was halomonas (species 1, 2, & 3).In addition, the rn stated that upon notice of the recall, the patient had 3 unopened boxes of the recalled product that were removed from their home.The patient complained of chest tightness on the way to the hospital on (b)(6) 2015.However, there is no documentation in the medical records to indicate that a cardiac event occurred.The patient became anemic during the hospitalization and received a blood transfusion.There is no documentation in the medical record which indicates a cause for the patient¿s anemia.According to the physician notes, the patient was "admitted with line sepsis from the permacath." the permacath is not a fresenius manufactured product.There is no documentation in the medical record that indicates a causal relationship between the liquid bicarbonate and the patient's hospitalization for sepsis and hyperkalemia.In addition, the patient had a left neck wound at the line insertion site that had a positive culture.Furthermore, blood cultures drawn upon admission into the hospital were positive.The medical records do not contain gram stain results or final culture results for review.Based on the physician's note which states that the patient was admitted for an infected hemodialysis line, along with the positive line access wound culture and the nurse¿s statement that the patient was positive for (b)(6), it is not likely that the infection was causally related to the patient's use of fresenius hemodialysis products.

Event Description

A home therapy registered nurse (rn) from a home hemodialysis (hhd) clinic reported that a patient was hospitalized for a sepsis infection in (b)(6) 2015.The organism, (b)(6), was detected at a wound which resulted from the patient¿s removal of a band-aid at the access site.It should be noted the organism related to the recalled 08-4000-lb bicarbonate was halomonas (species 1, 2, & 3).(b)(6) was not an organism detected in product associated with the recall; however, the patient had received lots of recalled product and was potentially exposed.The patient¿s medical records were provided and revealed the following event details.The patient went to the emergency room (er) on (b)(6) 2015 with complaints of generalized pain, weakness, chills, and a temperature of 102 degrees fahrenheit.In the er, the patient's temperature was 103.1 degrees fahrenheit and the patient was hyperkalemic.On the way to the hospital, the patient complained of chest tightness and shortness of breath.Upon arrival, the patient denied having chest pain and no tachycardia, shortness of breath, wheezing, or cyanosis was noted.The patient was admitted into the intensive care unit (icu) and diagnosed with acute line sepsis and end stage renal disease (esrd) with hyperkalemia.Patient received emergent hemodialysis (hd).In addition, the patient was administered antibiotics.On (b)(6) 2015, the patient was transfused blood for hemoglobin (hgb) of 7.5 and hematocrit (hct) of 25.1.During hospitalization, the patient was dialyzed through an arteriovenous (av) fistula.In addition, vascular surgery was performed to remove the patient's hemodialysis catheter from the left side of the neck.A wound culture performed on the left side of the neck was positive, but the medical records fail to document the organism.The patient's fever improved.

• Brand Name: LIQUID BICARBONATE 4000 FMC 3 BOT/CS
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 383 rue joseph-carrier; vaudreuil-dorion, qc, j7v 5v5 J7V 5 V5; CA J7V 5V5
• Manufacturer (Section G): FRESENIUS MED. CARE (HAEMOTEC); 383 rue joseph-carrier; vaudreuil-dorion, qc, j7v 5v5 ; CA
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5833600
• MDR Text Key: 50755615
• Report Number: 1225714-2016-00130
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08-4000-LB
• Other Device ID Number: 00840861101931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1639-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 172