MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 191126

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

Patient Problems Tachycardia (2095); Burning Sensation (2146)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there is no allegation of a fresenius 2008t hd machine malfunction or deficiency related to the reported event.

Event Description

It was reported to fresenius that a hemodialysis (hd) patient experienced symptoms of a burning sensation in their chest and tachycardia during an hd treatment.After 2 hours and 37 minutes into the patient¿s treatment, the patient began experiencing these symptoms as their pulse rate increased within the range of 122 to 137 bpm.The treatment was discontinued, and the patient was placed on 100% oxygen through a non-rebreather mask.The patient was transported to the emergency department (ed) where it was found the patient¿s symptoms were caused by an undiagnosed cardiac condition that was unrelated to hd therapy.The patient was prescribed oral eliquis (unknown dose, frequency and duration) as a blood thinner and released from the ed to home on the same day.It was confirmed by the outpatient clinic physician that the patient¿s symptoms and the associated ed visit were unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues hd therapy on an in-center basis following this event with no further incident.Based on the available information, there was no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.

Event Description

It was reported to fresenius that a hemodialysis (hd) patient experienced symptoms of a burning sensation in their chest and tachycardia during an hd treatment.After 2 hours and 37 minutes into the patient¿s treatment, the patient began experiencing these symptoms as their pulse rate increased within the range of 122 to 137 bpm.The treatment was discontinued, and the patient was placed on 100% oxygen through a non-rebreather mask.The patient was transported to the emergency department (ed) where it was found the patient¿s symptoms were caused by an undiagnosed cardiac condition that was unrelated to hd therapy.The patient was prescribed oral eliquis (unknown dose, frequency and duration) as a blood thinner and released from the ed to home on the same day.It was confirmed by the outpatient clinic physician that the patient¿s symptoms and the associated ed visit were unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues hd therapy on an in-center basis following this event with no further incident.Based on the available information, there was no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.

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.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• 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: 11530920
• MDR Text Key: 241424484
• Report Number: 2937457-2021-00461
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• PMA/PMN Number: K173972
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 59