MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,05 report with the FDA on 2009-12-23 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp..
[1315114]
The customer alleged the unit was leaking. The customer stated there was a leak coming from the center apparatus inside the unit. It was discovered that the relief valve on the air compressor was leaking, indicating the air valve may have malfunctioned. The customer did not have a service box available. Subsequently, the customer stated the unit leaked a combination of cidex opa solution and water onto the floor. The customer and another healthcare worker experienced burning eyes and a headache; the symptoms cleared after approximately 30 minutes. No medical attention was sought. No over-the-counter eye drops were used. The customer left the room. The customer stated the unit is in operation. The unit is not leaking. The customer had scheduled the unit to be repaired by a certified repair person outside of asp. A service was not dispatched.
Patient Sequence No: 1, Text Type: D, B5
[8343957]
(b) (4). Capital equipment evaluated at the customer site. The customer had scheduled the unit to be repaired by a certified repair person outside of asp. All related mdrs: 2150060-2009-00181, 2150060-2009-00182.
Patient Sequence No: 1, Text Type: N, H10
[8874511]
Asp investigation summary: the investigation included for the aer: device history record review, service history review, complaint trending by problem codes, failure mode and effects analysis, and health hazard evaluation, and for cidex opa: failure mode and effects analysis, system hazard use and misuse analysis and a corrective and preventative action plan. The dhr (device history record) for this aer unit was reviewed and it revealed the unit met the manufacturer's specifications at the time of release. Within the past six months ((b)(6) 2009), this aer unit per account history has not observed a significant trend of this same issue. A review of the complaint history for aer units with problem code "fluid leak" did not reveal a significant trend over the past 12 months ((b)(4) 2010). A review of the complaint history for aer units with problem code "hr-headache" revealed that (b)(4) complaints were reported over the past 12 months ((b)(4) 2009 - (b)(4) 2010), which is an average of less than (b)(4) complaints per month; and therefore, does not indicate a significant trend. A review of the complaint history for aer units with problem code "hr-eye burning" revealed that three complaints were reported over the past 12 months ((b)(4) 2009 - (b)(4) 2010), which is an average of less than (b)(4) complaint per month; and therefore, does not indicate a significant trend. An assessment of the aer fmea revealed the rpns (risk priority number) for all leak related failure modes are below the threshold of 100 indicating that the associated risks are minimal. The hhe (health hazard evaluation) was reviewed for similar disinfectant leak of the aer and the hazard/risk index was 4 which indicated the associated risk is low. An assessment of the cidex opa solution fmea (failure mode and effects analysis) revealed the rpn (risk priority number) for spills/leaks is below the threshold of 100 which indicated the associated risk is minimal. The cidex opa solution/disopa shuma (system hazard use and misuse analysis) was reviewed and it was determined that the risks of user exposure due to spills all fall into category i. A capa (corrective and preventative action plan) was opened to investigate hcw (healthcare worker) reports of human reaction symptoms while working with cidex opa solution. Through the investigation, it was determined that inadequate ventilation and/or possibly user related issues were contributing to the majority of these reported human reaction symptoms. Cidex opa solution was a concomitant product. The asp tsr (technical service representative) troubleshot with the customer and found that the relief valve on the air compressor was leaking which suggested that the air valve might be malfunctioning/stuck open. The customer did not have a service box available, so the asp tsr instructed the customer to change the air valve (v3) with the waste valve (v6) and monitor the level of disinfectant in the reservoir both before and after an empty cycle. The asp tsr also provided the customer with the part number for the skinner valve. Upon follow-up, the customer stated that a few drops of water were leaking from the air compressor valve during the disinfect cycle when the unit was draining. The asp tsr gave the customer the part number for the air compressor assembly. The root cause was determined to be inadequate ventilation and inadequate ppe (personal protective equipment). The hcw was not wearing ppe. The cidex opa solution instructions for use (ifu) states that exposure to ortho-phthalaldehyde vapors should be avoided as they may be irritating to the eyes and may cause headache. In case of adverse reactions from inhalation of vapor, it is recommended that the individual move to fresh air. The ifu (instructions for use) and msds (material safety data sheet) also state that cidex opa solution should be used in a well-ventilated area and in closed containers with tight-fitting lids. If adequate ventilation is not provided by the existing air conditioning system, use in local exhaust hoods, or in ductless fume hoods/portable ventilation devices which contain filter media which absorb ortho-phthalaldehyde from the air. The ifu also states that eye protection should be worn. The msds states that cidex opa solution may cause irritation and redness to the eyes. A letter was sent to the customer recommending review of the enclosed copies of the ifu and msds. The customer did not respond to asp's attempts to obtain more information; thus, resolution of the issue could not be confirmed. Conclusion: changed from "67" to "80".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00182 |
| MDR Report Key | 1575979 |
| Report Source | *,05 |
| Date Received | 2009-12-23 |
| Date of Report | 2009-12-01 |
| Date of Event | 2009-12-01 |
| Date Mfgr Received | 2011-01-10 |
| Date Added to Maude | 2011-01-27 |
| 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 STEMBERGER |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-12-23 |
| 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 | N |
| 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 | 2009-12-23 |