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 Hematoma (1884); Respiratory Failure (2484); Multiple Organ Failure (3261)

Event Date 01/16/2022

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between the patient¿s respiratory failure leading to his death and hd therapy utilizing a hospital provided 2008t hd machine.The root cause of the patient¿s death can be attributed to respiratory failure as reported by a medical professional.It is well known respiratory failure is one of the leading causes of hospital in-patient mortality.Additionally, this patient had multi-organ failure which carries a high risk of mortality for the critically ill and significantly reduced the chance of survival for this patient.Therefore, the 2008t hd machine can be excluded as a source or contributor to this patient¿s adverse event.Based on the required 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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a hemodialysis (hd) patient coded and expired while connected to the 2008t machine.The machine was left unattended with blood lines still attached.The staff was able to run an acid clean & mandatory rinse.During chemical disinfect (bleach), the machine displayed a system leak, can't run message (yellow banner) at the 2 minute counter time.Technical support advised to run a inlet water pressure regulator check, adjust pressure if needed or replace water inlet pressure regulator, swap heat exchanger (might be leaking internally) or possible pressure transducer #9 issue if issue continues.Upon follow up with a hospital hd registered nurse, it was reported this critically ill patient expired during an hd treatment due to respiratory failure while hospitalized.The patient was initially admitted to the hospital on (b)(6) 2022 following a fall with the formation of a large hematoma in the abdomen.The patient was not previously a chronic hd patient but due to the patient¿s rapid deterioration, multi-organ failure occurred including renal failure.The patient was given a second hd treatment on a hospital provided 2008t hd machine on (b)(6) 2022 15 minutes into the hd treatment, the patient went into respiratory failure.It was the decision of the patient¿s family to discontinue life saving measures and the patient expired shortly after a do-not-resuscitate order was placed.It was confirmed the patient¿s death due to respiratory failure was unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

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 that a hemodialysis (hd) patient coded and expired while connected to the 2008t machine.The machine was left unattended with blood lines still attached.The staff was able to run an acid clean & mandatory rinse.During chemical disinfect (bleach), the machine displayed a system leak, can't run message (yellow banner) at the 2 minute counter time.Technical support advised to run a inlet water pressure regulator check, adjust pressure if needed or replace water inlet pressure regulator, swap heat exchanger (might be leaking internally) or possible pressure transducer #9 issue if issue continues.Upon follow up with a hospital hd registered nurse, it was reported this critically ill patient expired during an hd treatment due to respiratory failure while hospitalized.The patient was initially admitted to the hospital on 12/jan/2022 following a fall with the formation of a large hematoma in the abdomen.The patient was not previously a chronic hd patient but due to the patient¿s rapid deterioration, multi-organ failure occurred including renal failure.The patient was given a second hd treatment on a hospital provided 2008t hd machine on (b)(6) 2022 15 minutes into the hd treatment, the patient went into respiratory failure.It was the decision of the patient¿s family to discontinue life saving measures and the patient expired shortly after a do-not-resuscitate order was placed.It was confirmed the patient¿s death due to respiratory failure was unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13393136
• MDR Text Key: 284701847
• Report Number: 2937457-2022-00144
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2018
• 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): Death; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 96 KG