MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,05 report with the FDA on 2009-12-10 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp..
[8924047]
Asp investigation summary: the investigation included a service history review, complaint trending by problem code, failure mode and effects analysis, system hazard and user misuse analysis and health hazard evaluation. The dhr for this aer unit was not reviewed as the root cause was determined to be use error and not manufacturing related. Within the past six months ((b)(4) 2009 - (b)(4) 2009), this unit, per account history, does not show any similar issues due to incorrectly setting the disinfect time on the aer unit. Thus, there is not a significant trend. A review of the complaint history for aer units with problem code "e09-disfectant time not entered" did not reveal a significant trend over the past 12 months ((b)(4) 2009 - (b)(4) 2010). An assessment of the aer fmea (failure mode and effects analysis) revealed the rpn (risk priority number) for high level disinfect cycle time related failure mode is below the threshold of 100, indicating that the associated risk is minimal. An assessment of the cidex opa solution fmea (failure mode and effects analysis) revealed the rpn (risk priority number) for insufficient exposure time is below the threshold of 100, indicating that the associated risk is minimal. The cidex opa solution/disopa shuma (system hazard and user misuse analysis) was reviewed and it was determined that the risk due to improper soaking is a category ii - alarp (as low as reasonably practicable). The hhe (health hazard evaluation) was reviewed for similar issues of a shorter disinfect time on the aer and the hazard/risk index was 6, which indicates the associated risk is low. The root cause was determined to be use error of incorrectly setting the disinfect time on the aer unit. Upon follow-up, the customer stated that the aer was no longer in service. The customer refused to provide any further information. A letter was sent to the customer recommending they review the ifu (instructions for use) for their disinfectant of choice and to follow all directions for use.
Patient Sequence No: 1, Text Type: N, H10
[20923354]
The customer alleged the disinfect cycle time on the aer unit was set at one minute and the wash cycle was set at five minutes. It was documented. Asp informed the customer the aer unit with the heater requires a disinfect time of five minutes. It was reported that the customer used this setting since 2008. The customer does not know when in 2008 or how many scopes were processed. It was reported that facility's biomedical engineer believed the heater lamp was off. Asp advised the customer to reset the unit to a minimum of one minute wash and to reset the disinfect time to five minutes since the unit is equipped with a heater. An asp clinical education consultant (cec) contacted the customer and followed up with the issue.
Patient Sequence No: 1, Text Type: D, B5
[21200263]
(b)(4) - disinfect time. All related mdrs: 2150060-2009-00173 and 2150060-2009-00174.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00174 |
| MDR Report Key | 1575471 |
| Report Source | *,05 |
| Date Received | 2009-12-10 |
| Date of Report | 2009-11-12 |
| Date of Event | 2009-11-12 |
| Date Mfgr Received | 2011-01-07 |
| Date Added to Maude | 2011-01-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GINNY STAMBERGER |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 96218 |
| Manufacturer Country | US |
| Manufacturer Postal | 96218 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | MINNTECH CORP. |
| Manufacturer Street | 14605 28TH AVE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-12-10 |
| Model Number | NA |
| Catalog Number | 20301 |
| Lot Number | NA |
| ID Number | PART #: NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINNTECH CORP. |
| Manufacturer Address | MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-10 |