MAUDE Adverse Event Report: CONCORD MANUFACTURING UNKNOWN-2008TBLUESTAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- 2008T BLUESTAR MACH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Failure (2484)

Event Date 07/01/2023

Event Type  Injury  

Event Description

A user facility registered nurse (rn) reported to fresenius that a rapid response code was called during a patient¿s hemodialysis (hd) treatment.Additional information was obtained through follow-up.This hd patient was present on 01/jul/2023 for a regularly scheduled hd treatment.At four hours and 15 minutes into the treatment, the patient got up to use the restroom.While in the restroom, the patient experienced a vasovagal episode and passed out.The patient¿s blood pressure had dropped to 46/33 mmhg and pulse was 164.The patient came to and exhibited a change in mental status (unspecified).The patient then went into respiratory arrest.A rapid response code was called and the team from the hospital responded as this dialysis clinic is located within the hospital.Cardiopulmonary resuscitation (cpr) was initiated.The patient¿s pulse oximetry went down to 76% with 3l o2 via nasal cannula so o2 was increased to 10l via face mask.The patient¿s blood was rinsed back, and the patient was administered a bolus of normal saline (volume not provided).There was no blood loss.The patient became responsive to verbal stimuli and was transferred to the emergency room (er).The patient was admitted to the hospital.The patient completed the hd treatment in the hospital.The patient received a complete cardiac workup and was found to have low potassium (k+).The patient¿s hd prescription was changed to increase the k+ to 3.0k (initial prescription not provided).The patient was discharged from the hospital on 03/jul/2023.The physician instructed the patient to withhold regular dialysis on 04/jul/2023 and return to regularly scheduled treatments on 06/jul/2023.Per the hdrn, there was no issue with the patient¿s treatment or any issue with the dialysis machine or other fresenius products prior to the adverse event.The cause of the vasovagal episode leading to respiratory arrest was not confirmed.

Manufacturer Narrative

Clinical review: there is a temporal relationship between hemodialysis utilizing the 2008t bluestar hemodialysis machine and the patient event of vasovagal syncope resulting in respiratory arrest and the need for a rapid response code.However, there is no documentation in the complaint file to show a causal relationship between the patient¿s adverse event and treatment utilizing the 2008t machine.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.The patient reportedly got up to use the restroom during hd treatment and had a vasovagal episode in which he passed out.The patient¿s blood pressure dropped and there was a change in mental status after regaining consciousness.However, the patient then went into respiratory arrest.There were no reported issues with the treatment prior to the event.There were no issues with the machine or other fresenius products prior to the event.A cause of the vasovagal episode was not determined.Vasovagal syncope results from a failure in autoregulation of blood pressure, and ultimately, in cerebral perfusion pressure resulting in transient loss of consciousness.The etiology of the respiratory arrest was not established.A complete cardiac workup was subsequently completed on the patient.It was determined the patient had hypokalemia.Severe hypokalemia may lead to and cardiac arrhythmias and even death.Based on the available information and no allegation or evidence of a device malfunction or deficiency, the 2008t bluestar hemodialysis machine can be excluded as the cause of the patient¿s adverse event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility registered nurse (rn) reported to fresenius that a rapid response code was called during a patient¿s hemodialysis (hd) treatment.Additional information was obtained through follow-up.This hd patient was present on (b)(6) 2023 for a regularly scheduled hd treatment.At four hours and 15 minutes into the treatment, the patient got up to use the restroom.While in the restroom, the patient experienced a vasovagal episode and passed out.The patient¿s blood pressure had dropped to 46/33 mmhg and pulse was 164.The patient came to and exhibited a change in mental status (unspecified).The patient then went into respiratory arrest.A rapid response code was called and the team from the hospital responded as this dialysis clinic is located within the hospital.Cardiopulmonary resuscitation (cpr) was initiated.The patient¿s pulse oximetry went down to 76% with 3l o2 via nasal cannula so o2 was increased to 10l via face mask.The patient¿s blood was rinsed back, and the patient was administered a bolus of normal saline (volume not provided).There was no blood loss.The patient became responsive to verbal stimuli and was transferred to the emergency room (er).The patient was admitted to the hospital.The patient completed the hd treatment in the hospital.The patient received a complete cardiac workup and was found to have low potassium (k+).The patient¿s hd prescription was changed to increase the k+ to 3.0k (initial prescription not provided).The patient was discharged from the hospital on (b)(6) 2023.The physician instructed the patient to withhold regular dialysis on (b)(6) 2023 and return to regularly scheduled treatments on (b)(6) 2023.Per the hdrn, there was no issue with the patient¿s treatment or any issue with the dialysis machine or other fresenius products prior to the adverse event.The cause of the vasovagal episode leading to respiratory arrest was not confirmed.

Manufacturer Narrative

Correction: h6 (type of investigation), h10 (plant investigation) plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.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

A user facility registered nurse (rn) reported to fresenius that a rapid response code was called during a patient¿s hemodialysis (hd) treatment.Additional information was obtained through follow-up.This hd patient was present on (b)(6) 2023 for a regularly scheduled hd treatment.At four hours and 15 minutes into the treatment, the patient got up to use the restroom.While in the restroom, the patient experienced a vasovagal episode and passed out.The patient¿s blood pressure had dropped to 46/33 mmhg and pulse was 164.The patient came to and exhibited a change in mental status (unspecified).The patient then went into respiratory arrest.A rapid response code was called and the team from the hospital responded as this dialysis clinic is located within the hospital.Cardiopulmonary resuscitation (cpr) was initiated.The patient¿s pulse oximetry went down to 76% with 3l o2 via nasal cannula so o2 was increased to 10l via face mask.The patient¿s blood was rinsed back, and the patient was administered a bolus of normal saline (volume not provided).There was no blood loss.The patient became responsive to verbal stimuli and was transferred to the emergency room (er).The patient was admitted to the hospital.The patient completed the hd treatment in the hospital.The patient received a complete cardiac workup and was found to have low potassium (k+).The patient¿s hd prescription was changed to increase the k+ to 3.0k (initial prescription not provided).The patient was discharged from the hospital on (b)(6) 2023.The physician instructed the patient to withhold regular dialysis on (b)(6) 2023 and return to regularly scheduled treatments on (b)(6) 2023.Per the hdrn, there was no issue with the patient¿s treatment or any issue with the dialysis machine or other fresenius products prior to the adverse event.The cause of the vasovagal episode leading to respiratory arrest was not confirmed.

• Brand Name: UNKNOWN-2008TBLUESTAR
• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17270630
• MDR Text Key: 318559362
• Report Number: 0002937457-2023-00968
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2023

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 Catalogue Number: UNKNOWN- 2008T BLUESTAR MACH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 07/01/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/25/2023; 07/27/2023
• Supplement Dates FDA Received: 07/26/2023; 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male