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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between hemodialysis (hd) therapy utilizing the fresenius 2008t machine with cdx and the patient event of cardiopulmonary arrest with subsequent hospitalization resulting in open heart surgery and seizure.However, there is no documentation of a causal relationship between the adverse event and use of the machine.Additionally, there is no allegation of a machine malfunction or deficiency reported for this adverse event.The cause of the patient¿s cardiopulmonary arrest during hd treatment was attributed to a physiological condition for which the patient required open heart surgery.Cardiovascular disease is present in greater than 50% of patients undergoing dialysis with 40% of these patients having coronary heart disease.Based on the available information and no allegation of a malfunction or deficiency, the fresenius 2008t machine with cdx can be excluded as the cause of the patient¿s cardiopulmonary arrest with subsequent hospitalization resulting in open heart surgery and seizure.Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported by a user facility biomedical technician (biomed) that a fresenius 2008t machine passed functional testing and was authorized for release back to service following an adverse event.Additional information was obtained through follow-up with the hemodialysis registered nurse (hdrn).The hemodialysis (hd) patient was approximately 2 hours and 50 minutes into treatment on the 2008t machine with approximately 1 hour and 30 minutes remaining in the treatment when they complained of cramping.This was a common occurrence for this patient.The patient¿s treatment was turned down to minimum and they were administered 200ml of normal saline (ns).The patient reported feeling fine other than the cramping.A short time later (time not provided) the nurse heard the patient making loud gasps with abnormal breathing.The patient then became unresponsive.The patient¿s treatment was discontinued and 500ml of ns was administered.Cardiopulmonary resuscitation (cpr) was initiated and the automated external defibrillator (aed) was retrieved.911 was called.Shock was advised with the aed.A post-review of the aed indicated the patient was in ventricular tachycardia (v-tach) at the time of the event.The patient was transported to a local hospital and then transferred to a different hospital to meet the patient¿s needs.The patient was intubated for two days and then extubated to undergo open heart surgery.Subsequently, the patient suffered a seizure post-surgery.The patient remains hospitalized at this time.The hdrn stated there were no issues with the fresenius 2008t machine during the patient¿s treatment.The patient¿s adverse event was due to a physiological condition and not related to any malfunction or deficiency of the machine.The machine passed all functional testing and was released to be put back into service.The only recent change with the patient was her dry weight (not provided).The nephrologist had increased her dry weight.No reason for the change or weight was provided.No additional information was obtained.

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.

Event Description

It was reported by a user facility biomedical technician (biomed) that a fresenius 2008t machine passed functional testing and was authorized for release back to service following an adverse event.Additional information was obtained through follow-up with the hemodialysis registered nurse (hdrn).The hemodialysis (hd) patient was approximately 2 hours and 50 minutes into treatment on the 2008t machine with approximately 1 hour and 30 minutes remaining in the treatment when they complained of cramping.This was a common occurrence for this patient.The patient¿s treatment was turned down to minimum and they were administered 200ml of normal saline (ns).The patient reported feeling fine other than the cramping.A short time later (time not provided) the nurse heard the patient making loud gasps with abnormal breathing.The patient then became unresponsive.The patient¿s treatment was discontinued and 500ml of ns was administered.Cardiopulmonary resuscitation (cpr) was initiated and the automated external defibrillator (aed) was retrieved.911 was called.Shock was advised with the aed.A post-review of the aed indicated the patient was in ventricular tachycardia (v-tach) at the time of the event.The patient was transported to a local hospital and then transferred to a different hospital to meet the patient¿s needs.The patient was intubated for two days and then extubated to undergo open heart surgery.Subsequently, the patient suffered a seizure post-surgery.The patient remains hospitalized at this time.The hdrn stated there were no issues with the fresenius 2008t machine during the patient¿s treatment.The patient¿s adverse event was due to a physiological condition and not related to any malfunction or deficiency of the machine.The machine passed all functional testing and was released to be put back into service.The only recent change with the patient was her dry weight (not provided).The nephrologist had increased her dry weight.No reason for the change or weight was provided.No additional information was obtained.

• 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
• MDR Report Key: 11465454
• MDR Text Key: 239397526
• Report Number: 2937457-2021-00408
• 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
• Report Date: 09/15/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR