• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONCORD MANUFACTURING 2008K MACHINE 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 Problems Fall (1848); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Loss of consciousness (2418)
Event Date 09/01/2021
Event Type  Injury  
Manufacturer Narrative
Clinical review: a temporal relationship exists between hd therapy utilizing the unknown hd machine and the adverse event(s) of dizziness, hypotension, loss of consciousness, and fall (hitting head) which warranted hospitalization (>24 hours) on (b)(6) 2021. Given the information provided by the cm (no allegation or deficiency/malfunction), the patient likely experienced an episode of post-treatment orthostatic hypotension due to postural changes. Hypotension is the most prevalent complication associated with hd and occurs in approximately 25% of all treatments. Very often, the cause of the hypotension is multifactorial. Based on the totality of the information available, the unknown hd machine cannot be excluded from having a possible contributory role in the patient¿s hypotension, loss of consciousness and fall (hitting head). There is no allegation (per cm) or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction contributed to the events. If the machine is located/returned, a manufacturer evaluation may dissociate the unknown hd machine from having contributed to the serious adverse events. However, given the temporal relationship, the patient¿s allegations, and the lack of treatment data, this clinical investigation cannot disassociate the device from the serious adverse events. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
It was reported that a hemodialysis (hd) patient had passed out due to low blood pressure while trying to walk out on their own and hit their head repeatedly. During follow-up, the patient¿s clinical manager (cm) reported the patient became dizzy due to hypotension following the completion of hd therapy. The patient was hospitalized following the events; however, the admission diagnosis and hospital course are unknown. Additional information was requested (e. G. , patient demographics, discharge summary, treatment record), however the information was unavailable due to the patient¿s discharge to another facility. The patient has recovered from the events and is currently undergoing peritoneal dialysis (pd) for rrt. The cm reported there was no allegation being levied against any fresenius device(s) and/or product(s).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008K MACHINE
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 Key12923349
MDR Text Key281659461
Report Number2937457-2021-02389
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
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,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
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 Received12/07/2021
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: 12/03/2021 Patient Sequence Number: 1
-
-