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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING UNKNOWN-2008 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.  .
 
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Brand NameUNKNOWN-2008
Type of DeviceDIALYZER, 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 Key13957251
MDR Text Key288787733
Report Number2937457-2022-00517
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
Number of Events Reported1
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 Received03/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN- 2008 MACHINE
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received04/02/2021
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
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