MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIQUID BICARBONATE 4000 FMC 3 BOT/CS

Catalog Number 08-4000-LB

Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problems Fever (1858); Urinary Tract Infection (2120)

Event Date 07/08/2015

Event Type  Injury  

Manufacturer Narrative

The post market surveillance department is in the process of requesting pt medical records and treatment data info regarding the reported event of fever and hospitalization for bacteria in the urine.The actual device involved is not available for evaluation.A retrospective record review did not identify any nonconformance reports and/or abnormalities during the production of the sap identified lot that could have caused or contributed to the reported event.A definitive conclusion regarding the involvement of the product could not be reached without a physical examination of a complaint sample.The plant investigation revealed that lot 15amlb008 was recalled on (b)(6) 2015.A capa was initiated to address this issue.A supplemental medwatch will be submitted upon completion of the investigation.

Event Description

A registered nurse (rn) reported a pt used 2 lots of the recalled product.According to the rn, the pt developed a fever on (b)(6) 2015 but refused to go to the hospital at the time.She was admitted to the hospital on (b)(6) 2015 and reported to have e coli and pseudomonas in her urine.The rn stated she did not believe this was caused by the recalled product.The pt has an ileal conduit and, according to his rn, many other "co-morbid" conditions.The pt remains in the hospital.There is no sample available.

Manufacturer Narrative

The pt is a (b)(6) female whose relevant medical history includes esrd receiving hemodialysis three days a week, copd, hypertension, bladder cancer status post right ileostomy and left nephrostomy tube, with metastasis.From a urine sample obtained at the time of admission, (b)(6) were isolated, being the patient diagnosed with urinary tract infection and treated accordingly.It was also reported that the patient may have undergone hemodialysis therapy with the use of the bicarbonate that was recalled due to contamination with dietzia sp.Although the user facility received the reported lot(s) it is unknown if this product was used in the patient's hemodialysis treatment.Dialysis patients with end stage chronic renal failure are generally immunocompromised, with increased risk of infection, while on kidney replacement therapy.Moreover, cancer patients with a nephrostomy tube are also at high risk of urinary tract infection due to the absence of barriers between the environment and the urinary tract.It is, in fact, one of the most frequent complications in this type of patients.The urinary tract infection suffered by the patient can be classified as a community-acquired infection, because the patient was symptomatic on admission and the culture of the urine sample taken also on admission was positive.The microorganisms isolated in the urine sample (vre and pseudomonas aeruginosa) do not have any relationship with the microorganism isolated in the bicarbonate solution causing the product recall (dietzia sp).The use of bicarbonate solution during hemodialysis does not establish direct contact with the urinary tract of patients.

Event Description

Information received from medical records and additional follow up: patient presented at the hospital on (b)(6) 2015 with lethargy, confusion and shortness of breath.Patient is a (b)(6) female who presented to the emergency room on (b)(6) 2015 from an outside hospital with a chief complaint of fever.The patient had presented at the outside hospital with fever and after being evaluated was noted to have significant bacteria in her urine and was given ciprofloxacin.The patient had missed her dialysis on (b)(6) 2015.Patient's blood pressure was 145/83, heart rate was 84, and respirations were 26.Temperature 98.1.Patient was on oxygen at 4 liters per minute via nasal cannula and her oxygen saturation was 100%.The patient went into acute hypoxic respiratory failure secondary to fluid overload and was intubated and placed in the medical intensive care unit from (b)(6) 2015.The patient was found to have a right atrial thrombus due to her hemodialysis catheter and placed on heparin and coumadin.On (b)(6) 2015, the patient was admitted into a rehabilitation unit due to her impaired mobility and activities of daily living.While in rehabilitation, this patient required a transfusion of 2 units of packed red blood cells.Patient was discharged home on (b)(6) 2015.She continues on hemodialysis at her outpatient facility.

• Brand Name: LIQUID BICARBONATE 4000 FMC 3 BOT/CS
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; vaudreuil-dorion, qc ; CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE CANADA; 383 joseph-carrier; vaudreuil-dorion, qc J7V 5 V5; CA J7V 5V5
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451-1457 ; 8006621237
• MDR Report Key: 5015768
• MDR Text Key: 23527595
• Report Number: 1225714-2015-06438
• 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: health professional
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 08-4000-LB
• Device Lot Number: 15AMLB008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1827-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 41