Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 2008T HD SYS. CDX W/BIBAG BLUE STAR; 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 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191126
Device Problem Pressure Problem (3012)
Patient Problems Bruise/Contusion (1754); Infiltration into Tissue (1931)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A biomedical technician (biomed) contacted fresenius technical support to ask about an a.24 alarm code that occurred on a 2008t hemodialysis (hd) machine.The biomed was performing a machine evaluation because of an incident that occurred while the device was in-use a few days prior.It was reported that during a treatment, the blood pump speed spiked from 50 ml/min to 600 ml/min and infiltrated the patient.The biomed stated the treatment was discontinued and the patient went home.Additional information was obtained through follow-up with the biomed and the hd facility¿s charge nurse (cn).The cn confirmed the initially reported details.The cn stated the patient care technician (pct) had set the blood pump to a low speed of 50 ml/min, and when they closed the door on the blood pump, the speed jumped up to 600 ml/min.This was noticed right away, and it was reported that an a.24 alarm had also occurred.Because of the high increase in pump speed, the patient¿s vein was infiltrated and fluid spilled out into the non-vascular space of the patient¿s arm.It was confirmed that there was no blood loss due to the reported event.The cn reiterated that it was caught very quickly, and thus, the consequences were not severe.It was reported that the patient¿s blood was returned through the arterial line.The patient¿s treatment was discontinued and they were sent home to ice their arm.No medical intervention was required.The patient¿s arm was reportedly bruised when they returned to the hd facility for their subsequent treatment.However, the patient was cannulated without issue and able to complete their normal treatment.The patient was said to be continuing their regular hd therapy without further incident.Following the infiltration event, the 2008t machine was pulled from service for evaluation and the biomed confirmed that an a.24 alarm occurred during testing.The biomed replaced the motor/tach assembly and the a.24 alarm went away.No other parts had to be replaced or calibrated.After completing the repair, the machine passed all testing and was returned to service.The biomed stated there have been no further issues with the machine.The motor/tach assembly that was replaced was available to be returned for evaluation.The biomed stated they would send the part back via returned goods authorization (rga).
 
Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
A biomedical technician (biomed) contacted fresenius technical support to ask about an a.24 alarm code that occurred on a 2008t hemodialysis (hd) machine.The biomed was performing a machine evaluation because of an incident that occurred while the device was in-use a few days prior.It was reported that during a treatment, the blood pump speed spiked from 50 ml/min to 600 ml/min and infiltrated the patient.The biomed stated the treatment was discontinued and the patient went home.Additional information was obtained through follow-up with the biomed and the hd facility¿s charge nurse (cn).The cn confirmed the initially reported details.The cn stated the patient care technician (pct) had set the blood pump to a low speed of 50 ml/min, and when they closed the door on the blood pump, the speed jumped up to 600 ml/min.This was noticed right away, and it was reported that an a.24 alarm had also occurred.Because of the high increase in pump speed, the patient¿s vein was infiltrated and fluid spilled out into the non-vascular space of the patient¿s arm.It was confirmed that there was no blood loss due to the reported event.The cn reiterated that it was caught very quickly, and thus, the consequences were not severe.It was reported that the patient¿s blood was returned through the arterial line.The patient¿s treatment was discontinued and they were sent home to ice their arm.No medical intervention was required.The patient¿s arm was reportedly bruised when they returned to the hd facility for their subsequent treatment.However, the patient was cannulated without issue and able to complete their normal treatment.The patient was said to be continuing their regular hd therapy without further incident.Following the infiltration event, the 2008t machine was pulled from service for evaluation and the biomed confirmed that an a.24 alarm occurred during testing.The biomed replaced the motor/tach assembly and the a.24 alarm went away.No other parts had to be replaced or calibrated.After completing the repair, the machine passed all testing and was returned to service.The biomed stated there have been no further issues with the machine.The motor/tach assembly that was replaced was available to be returned for evaluation.The biomed stated they would send the part back via returned goods authorization (rga).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
2008T HD SYS. CDX W/BIBAG BLUE STAR
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
MDR Report Key11787981
MDR Text Key249909452
Report Number2937457-2021-01000
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102099
UDI-Public00840861102099
Combination Product (y/n)N
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? Yes
Device AgeMO
Initial Date Manufacturer Received 04/16/2021
Initial Date FDA Received05/06/2021
Supplement Dates Manufacturer Received05/12/2021
Supplement Dates FDA Received05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
Patient Weight69
-
-