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 Cardiac Arrest (1762)

Event Date 01/01/2020

Event Type  Injury  

Event Description

It was reported to fresenius via a voice of the customer (voc) survey response that they have decided to stay with incenter therapy because they once coded during hemodialysis (hd). Upon follow-up with the patient¿s clinic manager, it was documented that the patient has never coded during any treatment at their facility. The manager stated the patient once mentioned coding during a treatment prior to becoming a patient at fresenius (b)(4). It is unknown if the patient was a fresenius patient at the time of the reported coding event. Attempts to follow-up with the patient were unsuccessful. There was no allegation that there was a malfunction of any fresenius device that caused the patient to code during hd treatment. Based on the available information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.

Manufacturer Narrative

Clinical investigation: there was no allegation that there was a malfunction of any fresenius device that caused the patient to code during hd treatment. Based on the available information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue. 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). 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. Should additional relevant information become available, a supplemental report will be submitted.  .

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13957251
• MDR Text Key: 288787733
• Report Number: 2937457-2022-00517
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN- 2008 MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/02/2021
• 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 Treatment Data

Date Received: 03/30/2022 Patient Sequence Number: 1