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

Model Number 191128

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

Patient Problems Pulmonary Embolism (1498); Myocardial Infarction (1969)

Event Date 02/03/2023

Event Type  Death  

Event Description

On (b)(6) 2023 a biomedical technician (biomed) contacted fresenius technical support to request an inspection on a 2008t hemodialysis (hd) machine.A patient had expired on the machine.Additional information was obtained through follow-up with the registered nurse and the biomed.This male patient was a post-op (unspecified) hospital patient.On (b)(6) 2023 this patient completed hd treatment without complication.After the completion of treatment and prior to the patient being disconnected from the machine, the patient suffered a heart attack.The patient was administered cardiopulmonary resuscitation (cpr) without success.It was discovered that the patient also had a blood clot in his lung.The rn stated that the patient¿s heart attack was not related to the hd treatment or the machine, but that it is hospital policy for the machine to be inspected when a patient death occurs in relation to hd treatment.Follow-up with the biomed documented that the fresenius field service technician had just completed the machine inspection on (b)(6) 2023.The machine checked out good and passed all tests.The machine was being put back into service that day.

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between hd therapy utilizing the 2008t hd machine and the patient event of heart attack with subsequent death.However, there is no documentation in the complaint file to show a causal relationship between the adverse event and use of the 2008t machine.Additionally, there is no allegation of a machine malfunction or deficiency reported for this event.The hospital policy requires that the machine be inspected when in relation to any patient death.This patient was in the hospital as a post-op patient for an unspecified surgery.The patient had a blood clot in his lungs and suffered a fatal heart attack.Cardiovascular disease (cvd) is the major cause of morbidity and mortality in patients with end-stage renal disease (esrd) on hemodialysis (hd).At least (b)(4)% of patients with ckd have evidence of an ischaemic event (myocardial infarction or angina) at the time of presentation to a nephrologist.Based on the available information and no allegation or evidence of a malfunction or deficiency, the 2008t hd machine can be excluded as the cause of the patient¿s heart attack and death.

Event Description

On 07/feb/2023, a biomedical technician (biomed) contacted fresenius technical support to request an inspection on a 2008t hemodialysis (hd) machine.A patient had expired on the machine.Additional information was obtained through follow-up with the registered nurse and the biomed.This male patient was a post-op (unspecified) hospital patient.On (b)(6) 2023, this patient completed hd treatment without complication.After the completion of treatment and prior to the patient being disconnected from the machine, the patient suffered a heart attack.The patient was administered cardiopulmonary resuscitation (cpr) without success.It was discovered that the patient also had a blood clot in his lung.The rn stated that the patient¿s heart attack was not related to the hd treatment or the machine, but that it is hospital policy for the machine to be inspected when a patient death occurs in relation to hd treatment.Follow-up with the biomed documented that the fresenius field service technician had just completed the machine inspection on 09/feb/2023.The machine checked out good and passed all tests.The machine was being put back into service that day.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Investigation determines that there was no causal relationship between the objective evidence and the alleged event; the alleged event is unconfirmed.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. W/O CDX 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16351153
• MDR Text Key: 309266451
• Report Number: 0002937457-2023-00198
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

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: Other
• Device Model Number: 191128
• Device Catalogue Number: 191128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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 DIALYZER.; FRESENIUS DIALYZER.
• Patient Outcome(s): Death; Required Intervention; Life Threatening; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male