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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191130
Device Problem Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2022
Event Type  malfunction  
Event Description
A biomedical technician (biomed) at a user facility reported that the nylon cap on a rotor pin on the blood pump of a fresenius 2008t machine melted.The biomed stated that the issue was found when the machine was pulled from service after the bloodlines (a non-fresenius product) used for a patient¿s hemodialysis (hd) treatment were cut.A user facility registered nurse (rn) confirmed during followup that the patient was approximately 2 or 3 hours into treatment when the machine triggered an air detected alarm before the air could enter the bloodlines.The patient¿s blood was rinsed back and they did not experience blood loss, a serious injury, adverse event, or require medical intervention as a result of the reported issue.The biomed stated they did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melted blood pump rotor.The number of hours on the machine could not be confirmed however the machine is approximately one year old and the blood pump rotor is not original to the machine.The blood pump rotor was replaced, which resolved the machine issue, and that the machine was returned to service without any issues.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the melted blood pump rotor.The complaint sample has been returned to the manufacturer for physical evaluation.
 
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) at a user facility reported that the nylon cap on a rotor pin on the blood pump of a fresenius 2008t machine melted.The biomed stated that the issue was found when the machine was pulled from service after the bloodlines (a non-fresenius product) used for a patient¿s hemodialysis (hd) treatment were cut.A user facility registered nurse (rn) confirmed during followup that the patient was approximately 2 or 3 hours into treatment when the machine triggered an air detected alarm before the air could enter the bloodlines.The patient¿s blood was rinsed back and they did not experience blood loss, a serious injury, adverse event, or require medical intervention as a result of the reported issue.The biomed stated they did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melted blood pump rotor.The number of hours on the machine could not be confirmed however the machine is approximately one year old and the blood pump rotor is not original to the machine.The blood pump rotor was replaced, which resolved the machine issue, and that the machine was returned to service without any issues.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the melted blood pump rotor.The complaint sample has been returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
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).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 plant investigation was able to confirm the reported issue as it was determined that there was a causal relationship between the objective evidence and the reported event.
 
Event Description
A biomedical technician (biomed) at a user facility reported that the nylon cap on a rotor pin on the blood pump of a fresenius 2008t machine melted.The biomed stated that the issue was found when the machine was pulled from service after the bloodlines (a non-fresenius product) used for a patient¿s hemodialysis (hd) treatment were cut.A user facility registered nurse (rn) confirmed during followup that the patient was approximately 2 or 3 hours into treatment when the machine triggered an air detected alarm before the air could enter the bloodlines.The patient¿s blood was rinsed back and they did not experience blood loss, a serious injury, adverse event, or require medical intervention as a result of the reported issue.The biomed stated they did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melted blood pump rotor.The number of hours on the machine could not be confirmed however the machine is approximately one year old and the blood pump rotor is not original to the machine.The blood pump rotor was replaced, which resolved the machine issue, and that the machine was returned to service without any issues.Additionally, the biomed confirmed that there was no damage observed on any other components, or any other additional issues, associated with the melted blood pump rotor.The complaint sample has been returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Additional information: d9, h3 plant investigation: a sample was returned to the manufacturer for a physical evaluation.The sample consisted of a blood pump rotor.The blood pump rotor was returned with one of the rear guide sheaves (polymer sleeve) deformed and slightly dislodge from the guide pin.The guide sheave does not appear to be melted.The guide sheave is loose and can be easily removed from the guide pin.The returned blood pump rotor was installed onto the blood pump module of a test machine for testing.A patient test was performed with fresenius¿s combiset bloodline and water in dialysis.The patient test was performed at a blood pump rate of 120 ml/min for 15 minutes.The returned rotor did not puncture the bloodline and there were no leaks or air detector alarms during the patient test.The blood pump rate was increased to 600 ml/min for another 15 without any damage to the bloodline, leaks, or air detector alarms.There was no further damage to the guide sheaves and they did not fully dislodge from the pin during testing.There was no sign of a burning smell, smoke, spark, flame, arcing, or any other visible heat damage on the rotor during testing.A detailed inspection shows debris (material transfer) from the guide sheave on the cylindrical surface of the affected pin.There is debris inside the polymer guide sheave from the pin.The deformation of the guide sheave was caused by the rim of the rotor housing of blood pump module.The guide sheave would dislodge from the guide pin contacting the rim of the housing while turning.The investigation was able to confirm the reported issue.
 
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Brand Name
2008T HD SYS. W/O 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
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14659418
MDR Text Key296865009
Report Number0002937457-2022-00940
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102112
UDI-Public00840861102112
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 Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number191130
Device Catalogue Number191130
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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