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

Catalog Number UNKNOWN- 2008 MACHINE

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

Patient Problems Hypoxia (1918); Pulmonary Edema (2020); Vertigo (2134); Weight Changes (2607)

Event Date 01/16/2023

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a reported temporal relationship exists between hd therapy utilizing an unknown hemodialysis (b)(4), and the serious adverse events of weight fluctuations, lightheadedness, hypoxia, and pulmonary edema, which required evaluation in the er.The definitive etiology of the events is unknown; therefore, causality cannot be firmly established.It should be noted that an inability to obtain additional information precluded a more in-depth investigation.Based on the limited information available, the unknown hemodialysis (b)(4)can be excluded from having caused and/or contributed to the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction occurred.Furthermore, there is no report a fresenius device(s) and/or product(s) failed to meet user expectations and/or manufacturer specifications.

Event Description

On 25/jan/2023, fresenius became aware via a social media post (facebook) this anonymous patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) went to the emergency room (er)due to low oxygen (hypoxia), and fluid was discovered in the patient¿s lungs (pulmonary edema).The patient reported their dry weight may have changed, as it was previously 49.0 kilograms (kgs).The patient¿s weight recently has been between 41.6 kgs and 47.6 kgs.Lastly, the patient reported feeling lightheaded when too much fluid is removed.Attempts to obtain additional information (e.G., treatment record, discharge summary, hospital records, patient demographics) were not possible, as the patient¿s outpatient clinic and demographics are unknown.Therefore, the file will be processed with the limited information available.

Event Description

On 25/jan/2023, fresenius became aware via a social media post (facebook) this anonymous patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) went to the emergency room (er)due to low oxygen (hypoxia), and fluid was discovered in the patient¿s lungs (pulmonary edema).The patient reported their dry weight may have changed, as it was previously 49.0 kilograms (kgs).The patient¿s weight recently has been between 41.6 kgs and 47.6 kgs.Lastly, the patient reported feeling lightheaded when too much fluid is removed.Attempts to obtain additional information (e.G., treatment record, discharge summary, hospital records, patient demographics) were not possible, as the patient¿s outpatient clinic and demographics are unknown.Therefore, the file will be processed with the limited information available.

Manufacturer Narrative

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.

• Brand Name: 2008 MACHINE
• 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: 16269916
• MDR Text Key: 308441801
• Report Number: 0002937457-2023-00137
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- 2008 MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/15/2023
• 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
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization