MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190713

Device Problem Fluid/Blood Leak (1250)

Patient Problems Anemia (1706); Dehydration (1807); Unspecified Infection (1930); Dizziness (2194); Electrolyte Imbalance (2196); Anxiety (2328)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

On (b)(6) 2018, a copy of a voluntary medwatch was received from a hemodialysis (hd) clinic reporting that patient on hemodialysis (hd) for renal replacement therapy (rrt) experienced an adverse event during treatment.After review of the medwatch and medical records received 06/05/2018, this patient came to the hd clinic on (b)(6) 2018 for a scheduled two hour and 45 minute of hd treatment.Pre-dialysis vital signs were blood pressure (bp) 146/95, pulse 81, respirations (resp) 20, temperature 96.2°.The patient reported feeling dizzy prior to initiation of therapy, but demanded to come to treatment.The patient¿s therapy was initiated at 1016 hours without any issues.Approximately fifty minutes into treatment (1101 hours), the patient reported feeling dizzy, anxiety, sense of impending doom and lightheadedness.The patient bp was documented as 131/69 and pulse 84.At that time, the fresenius 2008t machine began to alarm (unspecified alarm) at which point the venous blood was noted to be black in color and clotted.The machine indicated that 338ml of fluid had been removed.The patient¿s arterial blood was then returned and she was administered 450ml normal saline (medwatch states 700ml).The patient requested to go to the hospital and 911 was called for emergency medical services (ems).At this time (1107 hours) the treatment was discontinued and the venous line was not returned.Vitals prior to transport were recorded as bp 152/96, pulse 75, resp 18.The patient was transported to the emergency room (er) via ems where she was evaluated for dizziness and nausea.The patient was diagnosed with dialysis disequilibrium syndrome, dehydration, anemia, electrolyte abnormality, hyperkalemia, dysrhythmia, and infection (unspecified).The patient¿s lab results were consistent with her esrd and potassium level showed within normal limits (4.0mmol/l).An ekg does not show any changes.Nephrology was consulted and it was determined that the patient could return to hd therapy for her next scheduled treatment on (b)(6) 2018 and that no additional treatment was required.The patient¿s condition was improved and she was discharged to home approximately five hours after admission to the er.No hospital course is known.Upon follow up, the clinical manager reported that patient¿s estimated blood loss (ebl) was approximately 200 ml.Additionally, the clinical manager confirmed that the patient has returned to her scheduled hd treatment with no reported issues.Upon inspection of the 2008t hemodialysis machine by the biomedical engineer (biomed), a small hole was noted in the line returning to the machine from the blue hansen connector.The machine had passed functional testing prior to initiation of hd treatments.Functional testing was done by the biomed and the machine passed testing.The machine currently remains sequestered until inspection by a fresenius regional equipment specialist (res).Additional information obtained through the biomed documented that there was no hemolysis experienced by the patient.Per the biomed, the hose clamp for the dialysate hose has sharp edges that are cutting into the silicone resulting in leaks.

Manufacturer Narrative

Additional information: (medical records) clinical investigation: there is a possible causal relationship between the patient symptoms of dizziness, anxiety, sense of impending doom and lightheadedness with subsequent hospitalization resulting from dark and clotted blood during hd treatment on the fresenius 2008t machine.However, the treatment records from the date of event document that the patient reported dizziness prior to the start of treatment, so it is unknown if the patient¿s pre-existing symptoms contributed to the event.The biomed documented that there was a small hole in the line returning to the machine from the connector which he reports being caused by sharp edges on the hose clamp for the dialysate hose.The product has not been evaluated by a fresenius res therefore the alleged malfunction cannot be confirmed.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

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Manufacturer Narrative

The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.A serial number search in the complaint system found one previous customer experience with the issue of venous pressure alarm within 90 days of the notified date.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7580458
• MDR Text Key: 110447869
• Report Number: 2937457-2018-01650
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 100 DEXTROSE; BICARBONATE (45X); FRESENIUS 160NRE OPTIFLUX DIALYZER; FRESENIUS BLOODLINES; GRANUFLO 2.0K, 2.0 CA, 1.0 MG; NATURALYTE 4000 RX12
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 46