MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-09 for HLD SYSTEMS 610 NA manufactured by Cenorin Llc.
[16058841]
Cenorin was contacted by a customer requesting technical service on (b)(4) 2012. They stated that the temperature reading on their washer/pasteurizer, model 610, was displaying on the user interface screen and the paper report strip a temperature of 385 degrees fahrenheit during the pasteurization mode. The hospital staff stated that as soon as the main tank was full of the required amount of water, the unit read 385 degrees fahrenheit. The unit then started the pasteurization process. Normal pasteurization temperature for this mode on this unit is 162 degrees f, +/- 1 degree f. A cenorin technical support engineer visited the customer on (b)(6) 2012, to review the situation and report findings. He found the unit turned off, unplugged, with a label placed on the unit stating "do not use". After initial review, the engineer speculated the temperature reading error was due to the failure of the temperature sensor component. The existing sensor was removed and replaced with a new temperature sensor. The unit was then tested and the unit demonstrated the temperature reading error was corrected and the unit was functioning correctly.
Patient Sequence No: 1, Text Type: D, B5
[16425279]
The old temperature sensor was returned to cenorin for further eval by engineering on (b)(4) 2012. Engineering installed the old sensor into a model 610 and found the sensor to function properly. After further review by engineering, it was speculated the sensor had not been "initialized" by the control function and thus could not correctly report the temperature accurately. The source of this potential event has yet to be determined. If this failure mode speculation is correct, the model 610 may provide a false positive for attaining pasteurization temperatures. For example, if the actual water temperature of the water in the tank is less than required for pasteurization and the model 610 is reading 385 degrees fahrenheit, the model 610 will continue with the pasteurization cycle given the control system requires a minimum temperature recorded to be above 160 degrees f, even though the actual water temperature may be below the required 160 degrees f. Potential risk: medical devices that were placed in the model 610 to be pasteurized may not have been subjected to the correct temperatures and thus not fully pasteurized. Mitigation processes were present in this occurrence to address such a failure. In this event, the control system did notify the users by the screen and paper printout that the temperature was excessively elevated and not within a temperature range achievable in this setting. Further, the unit had a placard that warned the user "water temperature not to exceed 165 degrees f". The paper strip chart is also designed to encourage the user to review each cycle where all relevant parameters are documented to assist in quality checks for the completeness and safety of each cycle. Hospital practitioners have the responsibility to maintain quality control process per (b)(4) and quality assurance standards. Cenorin engineers visited the customer's site again on (b)(4) 2012, to check their model 610 and evaluate past records to determine exactly when this false high temperature issue began and how often it occurred until it was reported by the customer on (b)(6) 2012. From what was reviewed at the time of the visit, there was a total of 13 pasteurization cycles completed with the temperature reading of 385 degrees f prior to notifying cenorin (b)(4). It was noted that some of the cycle reports were initiated by the user, which indicates that it was reviewed. For all of the other cycle reports reviewed, there were no comments or entries provided by the users to address the out of range temperatures. Cenorin is continuing its investigation/root cause analysis to determine specific sources of this problem and possible mitigations to resolve this issue. We will notify all of our model 610 customers via certified letter and email to advise them to verify their screen and printout records, take corrective actions when the temperature out of range incidents occur, and notify them of any further action cenorin will be making to assure product safety. We plan to release this letter to our customers by 01/14/2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004153171-2013-00001 |
| MDR Report Key | 2913436 |
| Report Source | 05,06 |
| Date Received | 2013-01-09 |
| Date of Report | 2013-01-09 |
| Date of Event | 2012-11-26 |
| Date Mfgr Received | 2012-11-26 |
| Device Manufacturer Date | 2009-07-08 |
| Date Added to Maude | 2013-04-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENETTE BENNETT, MANAGER |
| Manufacturer Phone | 2533952400 |
| Manufacturer G1 | CENORIN LLC |
| Manufacturer Street | 6324 SOUTH 199TH PLACE, SUITE 107 |
| Manufacturer City | KENT WA 98032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98032 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HLD SYSTEMS |
| Generic Name | WASHER/PASTEURIZER |
| Product Code | ECG |
| Date Received | 2013-01-09 |
| Model Number | 610 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENORIN LLC |
| Manufacturer Address | KENT WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-09 |