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

Model Number 2008T

Device Problems Fluid/Blood Leak (1250); Pumping Problem (3016)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/30/2016

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: the identified leak in the red hansen tubing is a possible contributor to the patient¿s hypotensive episode and subsequent allegation of the hd machine pulling off too much fluid.However, the patient sustained no serious injury or untoward effect and was able to complete hd treatment the following day without incidence.Additionally, the nurse stated that the patient has successfully completed the subsequent three hd treatments with no issues and without the need of any additional medical intervention since the hypotensive incident.The biomedical technician cut out the section of the damaged tubing then re-attached the tubing.Follow up information was received indicating that a complete system check on the hd machine was done and all parameters were within specification and the hd machine is ready to be put back into service.

Event Description

A user facility clinic manager reported that a patient experienced a drop in blood pressure and started to lose consciousness while undergoing a hemodialysis (hd) treatment on a 2008t hd machine.The patient was stabilized through the administration of normal saline.Subsequently, the hd therapy was prematurely terminated, and the patient was scheduled for an additional hd treatment the following day, (b)(6) 2016, which was completed without issue.The hd treatment was initiated at 4:48pm and at 4:50pm, the patient¿s vitals remained stable and the patient denied having any complaints.The patient¿s hd treatment continued with no reported adverse effects.At 6:00pm, the patient¿s hd treatment was interrupted.The patient was recirculating, arterial site re-cannulated, and the patient was rinsed back due to dark colored blood in the venous line and increased venous pressure (readings unknown).The dialyzer was rinsed, and then the hd treatment was resumed.Follow-up provided by the clinic manager revealed that there was no clotting of the blood, and no blood loss occurred.However, at 6:08pm, the treatment sheets document the premature termination of the hd therapy due to the venous needle clotting and low patient blood pressure.The supplementary medical records note that at the start of the hd therapy the patient¿s blood pressure was low with a recorded value of 96/83, and steadily trended down to 68/43.The patient¿s blood was rinsed back, and then 1500 milliliters (ml) of normal saline was administered, and the bp increased to 92/67.The clinic manager stated that the patient began to lose consciousness.The medical doctor (md) was notified of the patient¿s hypotensive incident and the decision was made to terminate the current hd treatment and schedule another treatment the following day.The patient returned to the clinic the next day and successfully completed the hd treatment as ordered without any further incidents.The patient continues to undergo routinely scheduled hd treatments without issue.No machine alarms were generated and no diagnostic messages were received during the patient's hd treatment.The clinic manager revealed that the machine appeared to be pulling off too much fluid at the time of the drop in the patient¿s blood pressure.The ultrafiltration (uf) goal was set to 3.3kg for a scheduled three (3) hour and 55 minute treatment.However, at the end of the hd therapy, the patient¿s dry weight was 82.2kg which reflected a change of -2.5kg.Therefore, a discrepancy exists between the total fluid removed of 825ml reported by the machine, when compared to the documented weight change on the hd treatment sheet, coupled with the reported administration of 2600ml of normal saline.After the patient was removed from the 2008t hd machine, a fluid leak was observed coming from the back of the machine.The leak was noted to be coming from a crack in the red hansen dialysate tubing near the silver clamp.The clinic manager felt that the hd machine compensated for the pressure loss by pulling too much fluid from the patient.Reportedly, the fluid leak occurred towards the end of the day, and no other issues were experienced during the hd treatments performed on this machine earlier in the day.Following the event, the 2008t hd machine was removed from service for evaluation by the biomedical technician.The damaged section of tubing was removed, and then the tubing was re-attached to restore the connection and resolve the issue.Functional testing performed by the biomed confirmed that the system was operating properly; all parameters were within specification.The hd machine is ready to be returned to service at the user facility.No fresenius dialyzer or bloodline product malfunction was alleged, observed, or identified, prior to, during, or following the event.The removed section of damaged tubing is available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.The biomedical engineer indicated that the unit was pulled from service for evaluation following the event.The damaged section of tubing was removed, and then the tubing was re-attached to restore the connection and resolve the issue.Functional testing performed by the biomed confirmed that the system was operating properly; all parameters were within specification.The 2008t hd machine is ready to be returned to service at the user facility.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 deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the material and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6300022
• MDR Text Key: 66462081
• Report Number: 2937457-2017-00075
• Device Sequence Number: 1
• Product Code: KDI
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/28/2017

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: 2008T
• Device Catalogue Number: 190713
• Other Device ID Number: 00840861100897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2011
• 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
• Treatment: CUSTOM COMBISET; OPTIFLUX 160NRE DIALYZER ASSEMBLY
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 81