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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS, HF 1500; SUBSYSTEM, WATER PURIFICATION
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VIVONIC GMBH AQUABPLUS, HF 1500; SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040105-US
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2022
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 user facility biomedical technician (biomed) reported that an aquabplus 1500 was failing the t1 test due to a defective p1 pump and was displaying the following alarm code: f-04-50-04.This occurred early in the morning before the clinic had opened; there was no patient involvement.Upon lifting the monitor hood of the reverse osmosis (ro) system, the biomed noticed that one of the cables was disconnected from the power switch.Additionally, the yellow cable lug on the disconnected cable was melted, charred, and had completely fallen off.The biomed confirmed that the other two cables remained connected.The biomed reconnected the cable and this resolved the reported issue.The biomed tried reattaching the damaged cable lug but it would not stay on.It was recommended they tighten the female connectors to get a better hold of the male part.The pump direction was checked; the two legs needed to be flipped, and then the pump was spinning correctly.After this was completed, the ro was able to pass the t1 test.The biomed stated a new set of power switch cables was ordered to replace these ones; they were still waiting for them to arrive at the time of follow up.The biomed confirmed that the ro did not have any service performed prior to this event.Additionally, the biomed did not recall the ro being worked on recently.There were no signs of any smoke, sparks, or flames.The thermal overload switch was not tripping, and there were no local power grid issues or environmental factors that could have contributed to the reported event.The biomed stated they would provide the ftp files, and send back the set of cables once they are replaced.A photo showing the cable with its missing cable lug was provided for review.
 
Manufacturer Narrative
Additional information: g1, h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.The reported event was confirmed by means of the provided information.The provided picture shows that unauthorized cable lugs were installed and attached to the motor protection switch.With these cable lugs, proper device performance cannot be guaranteed.A picture was reviewed from the final inspection of the device prior to use, and it shows that the device was installed with all three yellow cable lugs.The reported parts of the yellow insulation which were burned and fallen off could not be identified in the provided picture.The discoloration, disconnection, and charring of the non-specified cable lug was caused by bad contacting due to too low contact pressure between the crimp connector/cable lug and its contact pin at the motor protection switch.The low contact pressure resulted in high contact resistance at the connection point and high thermal power loss occurred.The connections between the wiring and the cable lugs connected to the contact pins can loosen over the time from repeatedly lifting the monitor hood for maintenance.Review of the machine files found several loggings that can confirm the described behavior.Several run-dry errors were found from march and could have been a contributing factor, as the frequent restart of the pump p1 means high starting currents and therefore high thermal energy on the power carrying parts, such as the cable lugs.A device history record (dhr) review was performed.The device was found to be conforming to the specifications and was confirmed to be released without any discrepancies.A review for similar complaints was not required, and a review of the machine¿s repair history was not either.Reproducing the reported failure pattern was also not necessary.Based on the information available, the reported event was confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus 1500 was failing the t1 test due to a defective p1 pump and was displaying the following alarm code: f-04-50-04.This occurred early in the morning before the clinic had opened; there was no patient involvement.Upon lifting the monitor hood of the reverse osmosis (ro) system, the biomed noticed that one of the cables was disconnected from the power switch.Additionally, the yellow cable lug on the disconnected cable was melted, charred, and had completely fallen off.The biomed confirmed that the other two cables remained connected.The biomed reconnected the cable and this resolved the reported issue.The biomed tried reattaching the damaged cable lug but it would not stay on.It was recommended they tighten the female connectors to get a better hold of the male part.The pump direction was checked; the two legs needed to be flipped, and then the pump was spinning correctly.After this was completed, the ro was able to pass the t1 test.The biomed stated a new set of power switch cables was ordered to replace these ones; they were still waiting for them to arrive at the time of follow up.The biomed confirmed that the ro did not have any service performed prior to this event.Additionally, the biomed did not recall the ro being worked on recently.There were no signs of any smoke, sparks, or flames.The thermal overload switch was not tripping, and there were no local power grid issues or environmental factors that could have contributed to the reported event.The biomed stated they would provide the ftp files, and send back the set of cables once they are replaced.A photo showing the cable with its missing cable lug was provided for review.
 
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Brand Name
AQUABPLUS, HF 1500
Type of Device
SUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
sailauf 63877
GM  63877
Manufacturer (Section G)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
sailauf 63877
GM   63877
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14376558
MDR Text Key291517471
Report Number3010850471-2022-00011
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040105-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received05/25/2022
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 Sequence Number1
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