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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

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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).
 
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Brand Name2008T HD SYS. CDX W/BIBAG BLUE STAR
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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11787981
MDR Text Key249909452
Report Number2937457-2021-01000
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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