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The levels were constantly abnormal.Use of anesthesia did not lower the levels.[device information output issue] no adverse event [no adverse event] case narrative: initial information has been received from an other non-health professional.Patient's information including the underlying/concomitant disease and medical history was not obtained.On an unspecified date, neuromuscular transmission monitor (tof watch) was used (lot no: 58-2010128, indication: product used for unknown indication).Other concomitant medication was not reported.On an unspecified date, "the levels were constantly abnormal.Use of anesthesia did not lower the levels" developed.At the time of the report, it was unknown when the malfunction occurred (e.G.Before or after surgery).At the time of the report, the outcome of "the levels were constantly abnormal.Use of anesthesia did not lower the levels" was unknown.Reporter's comment: not provided the reporter did not assess the seriousness of "the levels were constantly abnormal.Use of anesthesia did not lower the levels".The reporter felt that "the levels were constantly abnormal.Use of anesthesia did not lower the levels" was not related to neuromuscular transmission monitor.The case has been sent to mmd.Complaint description detail stop functioning - display - incorrect information displayed the displayed value is incorrect.It does not go down even with anesthesia.The complaint unit was returned to nihon khoden for the evaluation.Out of warranty/ paid replace; the complaint sample was replaced to optimal unit(s/n:(b)(6)).Replacement unit has been sent to the customer by nihon khoden.The case was closed under the nihon khoden support and no follow up necessary.Complaint unit was returned to menuma site, and it will be forwarded to biometer international.Felicity: a hospital 07 jan 2022, second person reviewed by reviewer a sign for: activity: document med device reportability by reviewer a 20jan2022, chu update on the returned unit, by reviewer b chu checked with nihon kohden on the condition of the returned unit.This repaired product was disassembled by nihon kohden.The customer's asset management label was affixed to both the upper and lower cases, and it was necessary to return the label.Since there is a high possibility that the label will be damaged when it is peeled off, the entire case was returned to the customer.Thus, only the tof inner base was returned.20 jan 2022, second person reviewed by reviewer a 20may2022 ; case reopened to attach drr email sent to pv.Complaint description summary stop functioning - display - incorrect information displayed -- the displayed value is incorrect.It does not go down even with anesthesia.Follow-up information received from costa rica global pharmacovigilance case management as attached.Follow-up information received on 17-may-2022.Email received in the mnsc pqc mailbox on 17-may-2022 at 10:52am from quality stating: "this record was cancelled in our system since confirmation was received from pharmacovigilance that this record is a duplicate complaint of case 22m-008, pr 352403 that was logged by dpoc japan".Executive summary immediate actions: the immediate action was for the customer to return the device to the distributor, nihon kohden.The device was checked, disassembled and the case only was returned to the customer as the customer asset management label was affixed to the upper and lower cases.The remaining parts of the complaint device will not be returned to the customer.No immediate actions have been taken regarding the other devices manufactured in lot 58-2010.A pqc trending query has been performed on 06.May.2022 on the number of complaints received for lot 58-2010 and the number of complaints received for the reported complaint category stopped functioning and complaint category details display ¿ incorrect information displayed for the impacted lot 58-2010.There are seven complaints received for lot 58-2010.This is the first complaint received related to stop functioning -display for lot 58-2010.As the alert/action limit set at 1/3 in the current lot threshold table, a full investigation and mdcp assessment is required.Complaint sample description: the device, patient main cable, acceleration transducer cable, positive stimulation lead (white), and negative stimulation lead (black) have been returned to the distributor, nihon kohden, and functionally analysed.The analysis confirmed the display of information at device start-up was defective.Visual analysis of the pictures received of the tof watch device, serial number (b)(6), showed the patient main cable and acceleration transducer cable did not appear to have knicks, twists, or permanent bends in the cable insulator that would be indicative of damage that may cause the device to not function as intended.The full condition of the terminations on the patient main cable and transducer cable could not be interrogated as these were not fully visible in the picture.Although the condition could not be evaluated, tape placed in the location of the connectors has been proven to prevent the stimulation and/or the measurement circuit from performing correctly or consistently in previous complaint investigations.The upper and lower case could not be interrogated for indications of damage.The front of the circuit board showed damage to the lower edge of the display and the back of the circuit board showed wear or corrosion to the outer contacts.Investigation details: tof watch is used for measurement of muscle relaxation using the train of four (tof) technique.This complaint is latent in nature on a device that was manufactured in 2010, sold in 2013, and is presumed to have been in service since 2013.Design mdcp -q risk assessment is as follows: a review of the risk management file for tof watch has been performed on may 16, 2022.The defect of "stopped functioning" is identified in the supplier's document, titled: risk management related to clinical use of tof-watch family of devices (supplier document number (b)(4), which is included in midas document id (b)(4), version 1.0).The related risk line # 8.6.1 describes the hazard of "poor readability/understanding of display/results", which pertains to the user and their ability to understand/interpret the tof watch interface.Based on the risk ranking table within the risk management related to clinical use of tof-watch family of devices, the risk region for the identified defect is acceptable.Component, raw material, device constituent, or device component release testing based on the duration the device was in use prior to the reported defect and condition of the device, no component, raw material, device constituent, or device component release testing was reviewed or repeated.Vendor / supplier investigation there is no relation to the vendor/supplier components in combination with the complaint category, therefore a supplier investigation is not required.Release testing based on the duration the device was in use prior to the reported defect and condition of the device, no release testing was reviewed or repeated at this time.Batch record review / device history record review /logs /deviations review based on the duration the device was in use prior to the reported defect and condition of the device, no device history record, manufacturing logs or deviation reviews were conducted.Review of previous capas no previous capas.Change controls based on the duration the device was in use prior to the reported defect, tof watch is no longer manufactured, or distributed, no change controls reviewed.Stability results no stability studies are performed for tof watch.Retention sample evaluation and testing no retains are available for tof watch.Information regarding warehousing / distribution based on the duration the device was in use prior to the reported defect, no warehousing/distribution information reviewed.Potential root cause: some damage was determined to be present based on analysis from the device pictures.The damage identified can be caused by storage, handling, or use throughout the life of the device.Placing tape at cable connectors can disrupt the electronic signal along the measurement circuit and can cause an incorrect value to be displayed.Based on previous tof watch pqc investigations for stop functioning and incorrect measurement of relaxation, other causes may be a damaged or poor cable connection of the acceleration transducer or main patient cable or a damaged internal device component such as a voltage regulator.Damage to these device components may cause the device to not function as intended including an incorrectmeasurement value.In summary, damage to device components during storage, handling, or use and the use of tape at connectors is a potential root cause and no further investigation will be performed.The return of the device prevents further device use and the decreases the likeliness of a hazardous situation.Impact on other products(s)/batches: this complaint relates to specific device handling or exposure situation and there is no impact on other devices in the same manufacturing lot or other lots based upon the potential root cause.Corrective actions: no corrective actions are required as a result of this complaint.From the information provided, msd has determined that this device is not suitable for use and needs to be decommissioned.We recommend replacement with an alternative device.
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