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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 1500; SUBSYSTEM, WATER PURIFICATION
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VIVONIC GMBH AQUABPLUS 1500; SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040105-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
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 user facility biomedical technician (biomed) reported that an aquabplus 1500 was experiencing a power problem.The biomed received a call from the facility when they were opening, reporting that the reverse osmosis (ro) system would not power on.During their troubleshooting, the local staff relocated the stage 2 power supply board and cable (going to the motherboard), to stage 1.This resolved the power issue.After doing this, the t1 test was completed without any problems.The biomed went to the clinic to evaluate the ro system.The biomed stated there were no alarm codes.Per the biomed, this was strictly a power-related issue.Upon further inspection, burn marks were identified on the cable connector that goes to the power supply motherboard.Replacement parts (a power supply and cable) were ordered.The reported failure resulted in a minor treatment delay (approximately 15 minutes); however, all patients were able to complete their treatments and none were sent home or to a different clinic.There was no patient harm.Other than the burnt cable connector, there were no additional damaged components found.There was no burning smell, smoke, sparks, or flames.In addition, there were no local power grid issues in the area.The biomed confirmed there were no blown fuses in the local power supply, and the thermal overload switch was not tripping.At the time of follow-up, the machine was fixed and fully operational.The parts were available to be returned for evaluation; the biomed stated they were packaged and ready to be sent back.Photos of the burnt cable connector were provided for review.The biomed was unable to provide the ftp machine files.There was no patient involvement associated with the reported event; the reported failure occurred prior to the start of any treatments.
 
Manufacturer Narrative
Additional information: b5, h3 plant investigation: although the sample was reported to be available for evaluation, to date no parts have been received by the manufacturer.The cause of the machine¿s power failure was a bad, overheated electrical contact at the power supply unit.The bad electrical contact is caused by an improper manufacturing process of the crimp and plug connection.The low contact pressure inside the housing of the plug connector resulted in thermal stress until the contact point became completely damaged as the machine continued to be used.As the reported failure pattern is a known issue, corrective actions are currently in progress to address the failure.The manufacturing process will be improved in the future when the corrective actions are completed.The new manufacturing process was not yet approved when the affected device was manufactured.Review of the machine files was not required as the issue is known to be unrelated to recorded operating data.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 of the repair history was not required, nor was reproducing the reported failure pattern.A review of the instructions for use (ifu) was not performed because the issue was not user related.A review of the service manual revealed that a visual inspection of the device is part of the technical safety check.Based on the available information and provided pictures, the reported event can be confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus 1500 was experiencing a power problem.The biomed received a call from the facility when they were opening, reporting that the reverse osmosis (ro) system would not power on.During their troubleshooting, the local staff relocated the stage 2 power supply board and cable (going to the motherboard), to stage 1.This resolved the power issue.After doing this, the t1 test was completed without any problems.The biomed went to the clinic to evaluate the ro system.The biomed stated there were no alarm codes.Per the biomed, this was strictly a power-related issue.Upon further inspection, burn marks were identified on the cable connector that goes to the power supply motherboard.Replacement parts (a power supply and cable) were ordered.The reported failure resulted in a minor treatment delay (approximately 15 minutes); however, all patients were able to complete their treatments and none were sent home or to a different clinic.There was no patient harm.Other than the burnt cable connector, there were no additional damaged components found.There was no burning smell, smoke, sparks, or flames.In addition, there were no local power grid issues in the area.The biomed confirmed there were no blown fuses in the local power supply, and the thermal overload switch was not tripping.At the time of follow-up, the machine was fixed and fully operational.The parts were available to be returned for evaluation; the biomed stated they were packaged and ready to be sent back.Photos of the burnt cable connector were provided for review.The biomed was unable to provide the ftp machine files.There was no patient involvement associated with the reported event; the reported failure occurred prior to the start of any treatments.More details were obtained through additional follow-up with the biomed.The biomed stated the power supply had not been working.The biomed was informed by an aquabplus technician to swap the good cable from stage 2 onto stage 1.This got the unit up and running until the new power supply and cable were delivered.The biomed confirmed the fuses were checked and none of them were thrown; they were all in working order.After installation of the new parts, the ro has run correctly without any problems.
 
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Brand Name
AQUABPLUS 1500
Type of Device
SUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
sailauf 63877
GM  63877
MDR Report Key12503057
MDR Text Key272415893
Report Number3010850471-2021-00025
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
PMA/PMN Number
K133829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
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
Device AgeMO
Date Manufacturer Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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