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); Insufficient Information (3190)

Patient Problems Edema (1820); Fever (1858); Headache (1880); Unspecified Infection (1930); Sepsis (2067); Chills (2191); No Code Available (3191)

Event Date 05/02/2014

Event Type  Injury  

Manufacturer Narrative

Further information from the complaint noted that the patient was a home hemodialysis patient who underwent dialysis treatment three times per week.Additionally, a recall notice sent to the patient from fresenius medical care stated that the referenced product was distributed to the patient between 08/15/2013 and 04/07/2014.More exact information has been requested and will be submitted upon receipt.(b)(4).A field corrective action was taken for this type of complaint for this product as alleged.However, product-specific information was not provided to confirm whether this product was one of the recalled lots.Additional information has been requested and will be submitted upon receipt accordingly.

Event Description

The plaintiff's attorney alleged that the patient was admitted to the hospital and diagnosed the plaintiff's attorney alleged that the patient was admitted to the hospital and diagnosed with bacteremia, sepsis and infection of the patient's dialysis catheter from exposure to the product.The patient experienced a gradual onset of constant and moderate chills.Associated symptoms included fever, dry cough, headache and right ear edema for one week.

Manufacturer Narrative

(b)(4).Updated narrative after device evaluation: the product has not been returned for analysis and the product model and lot numbers were not made available.Investigation was conducted for retained samples on lots against which similar allegations have been made.Retains were tested for microbiological contamination (bioburden); the retains were found to be above the current specification for bioburden (<100 cfu/ml).Although medical records pertaining to this event were requested, no further information regarding the reported event is available and a clinical investigation could not be performed.Without the requested additional information and clinical investigation, no conclusion can be drawn.Additional information has been requested and will be submitted upon receipt accordingly.

• 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 joseph-carrier; vaudreuil-dorion J7V 5 V5; CA J7V 5V5
• Manufacturer (Section G): MONTREAL; 383 joseph-carrier; vaudreuil-dorion J7V 5 V5; CA J7V 5V5
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5792601
• MDR Text Key: 49494588
• Report Number: 1225714-2016-00126
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 08-4000-LB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• 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
• Removal/Correction Number: Z-1639-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 40 YR