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

Model Number 190713

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Hypovolemia (2243)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Clinical investigation: a causal association exists between an observed leak from a tear in the hansen line of the 2008t machine and the patient¿s adverse event of excessive fluid removal, nausea, and hypotension during a dialysis treatment.The patient required early termination of the dialysis treatment and fluid replacement with normal saline.The patient resumed regularly scheduled hd treatment without report of any further serious injury.It cannot be determined what caused the tear to occur.However, a review of the 2008t hd system risk analysis was performed and excessive fluid removal and hypotension are known potential adverse effects with a system leak using the fresenius 2008t machine.

Event Description

A user facility biomedical technician (biomed) reported to fresenius that a 2008t hemodialysis (hd) machine had a tear in the red hansen line from the flange on the connector at back of the machine.The tear in the hansen line caused a leak during a patient¿s hemodialysis (hd) treatment which reportedly resulted in the patient being hyper-dialyzed and having to terminate dialysis treatment early.Further information about the reported event was obtained through additional follow-up with a hd nurse familiar with the event.The nurse indicated that pre-dialysis testing of the fresenius dialysis machine (per clinic standard) was completed, and the machine passed all pressure holding tests, machine alarms limits and conductivity tests.Subsequently, the patient was initiated on their regularly scheduled 3 hour and 45 minute hd treatment with the 2008t machine programmed for an ultrafiltration (fluid removal) goal of 2400ml.The patient¿s treatment was initiated without any reported issues, according to history provided by the hd nurse.Approximately 2 hours into the patient¿s dialysis treatment, the patient had complaints of nausea and the patient¿s blood pressure dropped.Additionally, the hd nurse reported the patient appeared as if they were going to lose consciousness.As a result, the machine¿s ultrafiltration (fluid removal) was turned off and the patient was administered 100cc of saline.Simultaneously, it was reported that the patient¿s venous blood line was about to clot.The patient¿s hd treatment was ended early via rinse back (return of the patient¿s blood) using the arterial blood line with a total of 500cc of normal saline.Per the hd nurse, during this clinical event a staff nurse noticed a fluid leak coming from the back of the 2008t dialysis machine.There were no reported alarms associated with the observed fluid leak.The nurse indicated the patient self-reported feeling better to the dialysis staff and had no further issues.The patient was deemed stable for discharge from the dialysis clinic.However, the patient reported having some additional complaints of nausea at home.Per the nurse, this did not require any further medical intervention and the patient was able to resume the next scheduled hd treatment without any adverse effects/serious injury.The fresenius dialysis machine was pulled from service after the clinical event.It was reported the hansen tubing on the back of the machine had a visible tear.The biomedical technician reported using fresenius ratcheting clamps and replaced both hansen lines (red/blue) on the machine.It was stated there was no sample of the torn hansen line available for manufacturer evaluation.The machine was subsequently returned to service without any further reported issues.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12870849
• MDR Text Key: 281840521
• Report Number: 2937457-2021-02344
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/24/2021

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: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 80 KG