MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number 190895

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

Patient Problem Bradycardia (1751)

Event Date 10/10/2021

Event Type  Death  

Event Description

A biomedical technician (biomed) reported to fresenius technical support that a hospitalized patient experienced an adverse event during a hemodialysis (hd) treatment.The biomed was asked to perform functional checks on the 2008t hd machine that was being utilized.There was no specific allegation the event was due to a deficiency or malfunction of any fresenius product.Additional information was obtained through follow-up with a hospital hd registered nurse (hdrn) familiar with the event.The hdrn reported that the patient became bradycardic during hd treatment and subsequently expired.The patient was initially admitted to the hospital on (b)(6) 2021 with a diagnosis of pneumonia.The patient became critically ill during this admission, and it was determined the patient¿s kidneys were failing.The patient was given an hd treatment on 10/oct/2021 with a hospital provided 2008t hd machine.It was confirmed the patient was not on chronic renal replacement therapy and this was the first hd treatment they underwent.One hour and forty-three minutes following the initiation of the hd treatment (total intended treatment time was two hours), the patient became bradycardic, and hd was discontinued.Blood was returned to the patient while the patient¿s bradycardia worsened, and the hospital cardiac arrest code team was alerted.After multiple rounds of resuscitation efforts were performed, the patient was pronounced deceased on (b)(6) 2021.The exact cause of the patient¿s death was not reported to this acute care unit; however, it was determined the patient¿s death was unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The 2008t hd machine involved in this event passed all functional checks by the hospital biomed and was culture negative through laboratory testing.The 2008t hd machine¿s ultrafiltration (uf) was found to be slightly off calibration but posed no threat to the patient.

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 temporal relationship exists between hd therapy utilizing a hospital provided 2008t hd machine and the patient¿s death.The cause of the patient¿s death cannot be determined; however, it was confirmed this event was unrelated to hd therapy or the use of any fresenius product(s) or device(s) by a medical professional.It is well known pneumonia presents an increased risk of mortality in the hospitalized elderly population.Therefore, the 2008t hd machine can be excluded as root cause of the patient¿s adverse event.Based on the available information, there is no specific allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s adverse event.

• Brand Name: 2008T GEN 2 BIBAG WITHOUT CDX
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• 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: 12776256
• MDR Text Key: 280505084
• Report Number: 2937457-2021-02248
• Device Sequence Number: 1
• Product Code: KPO
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190895
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2017
• 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; Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 106 KG