MAUDE Adverse Event Report: CONCORD MANUFACTURING UNKNOWN-2008; 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 Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy, utilizing a fresenius hd machine and the adverse event of the patient¿s body aches.Multiple attempts were made to acquire further details concerning this patient¿s adverse event; however, no additional information was obtained.In the intake, it was reported the patient ¿thought¿ they were having a heart attack which acknowledges a heart attack did not occur.Additionally, in the patient¿s statement, ¿machines need to explain to patients [sic] before they [1st] start on dialysis¿, it is unknown if this was in reference to this reported event; however, there was no indication the patient¿s body aches and ed visit were due to the performance of any fresenius product(s) or device(s).Presently there is no specific allegation or objective evidence indicating a serious injury, patient death, or other adverse event(s) occurred related to a fresenius product(s) or device(s).Additionally, there is no allegation a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the patient¿s body aches following an hd treatment and ed visit.The cause of the patient¿s body aches can be attributed to a known side effect of hd therapy.Additionally, in the operator¿s manual for the 2008t hemodialysis system, it states the patient may experience cramping due to poorly maintained acceptable fluid and/or electrolyte balance.Therefore, any fresenius product(s) or device(s) utilized by the patient for hd therapy can be excluded as a root cause of this patient's adverse event.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.

Event Description

Fresenius became aware of this hemodialysis (hd) patient on hd therapy, utilizing a fresenius hd device who had too much fluid removed during an hd treatment.The patient stated they experienced body aches and they thought they were having a heart attack, prompting an emergency department (ed) visit.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Multiple attempts were made to acquire further details concerning this patient¿s adverse event; however, no additional information was obtained.

• Brand Name: UNKNOWN-2008
• 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: 14805410
• MDR Text Key: 295051839
• Report Number: 0002937457-2022-01049
• 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
• Report Date: 06/24/2022

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: Health Professional
• Device Catalogue Number: UNKNOWN- 2008 MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 06/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention