MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-07-29 for PARKER BATH manufactured by Arjohuntleigh Polska Sp. Z O.o..
[50715522]
(b)(4). Additional information will be provided following the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[50715523]
It was initially reported to arjohuntleigh representative that: "the nurse supervisor reported that staff had issues while using an arjohuntleigh disinfectant in an arjohuntleigh bathing system. The staff were reported to be using proper protective equipment and following all instructions for use regarding dilution and application. One staff member reported nose bleeds and another staff member has reported a tumor in her nose, affecting her sinus, teeth and she has had headaches. "
Patient Sequence No: 1, Text Type: D, B5
[55352371]
(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events on parker bath, we have found one similar case where it appears there was a problem with disinfectant. That one complaint is related to a situation where the patient has touched their mouth with the disinfectant nozzle. Due to this situation the patient had a swollen mouth. In line to this information the complaint covers a different situation than the one reported now and here. Therefore after review we find this event to be isolated, against a vast number of use days with similar baths in the market. The device was being disinfected by a staff member, no patient was involved at the time when the event occurred. The facility has reported that after using disinfectant cleanser iv caregivers has side effects, injuries : one staff member reportedly had nose bleeds and after 1 week off duty, the symptoms stopped. The other staff member has reported a tumor in her nose which allegedly had an effect on sinus, teeth and she has had headaches) after using disinfectant- and in that way the device contributed to the event. Information provided indicates that all instructions for use were followed regarding dilution and application. Also caregivers during disinfection were using protective nitrile gloves, eye shields and face masks. We did not receive medical confirmation that the reported injuries were caused by using disinfectant. It was found during our investigation that facility has 2 errors in their disinfection procedure: they are not using cold water to disinfect and rinse the tubs. Facility had a bucket of full strength disinfectant with a "loofah" type brush that the staff were using to clean the accessories such as" the pads and stuff used during the bath". Please note that all devices are equipped with instruction for use (ifu) from the manufacturer which clearly inform how to maintenance and use the product. Ifu for parker bath contains warning: - "to avoid eye and skin damage, always use protective glasses and gloves. If contact occurs rinse with plenty of water. If eyes or skin becomes irritated, contact a physician. Always read the material safety data sheet of the disinfectant. " moreover ifu contains 'cleaning and disinfection instructions' which inform step by step how to correctly use the disinfection e. G. : - "check the mix ratio on the flowmeter so that it is in accordance with the setting range stated in ifu. " - "adjust water temperature so that the disinfectant mixtures reaches approximately 20? C" - "rinse all parts clean with plenty of water having a temperature of approximately 25? C (77? F) using the shower handle to remove disinfectant. " the safety data sheet of the disinfectant cleanser iv sds inform that user should: "wear protective gloves and eye protection. Wash thoroughly after handling. Do not breathe mist or dust. Store locked up. If on skin (or hair): remove immediately all contaminated clothing. Rinse skin with water. Wash contaminated clothes before reuse. If in eyes: rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If swallowed: rinse mouth. Do not induce vomiting. If inhaled: remove victim to fresh air and keep at rest in a position comfortable for breathing. " after reviewing the complaint it comes forward that the device was performing according to specification when the event occurred however the exact cause of the reported injuries cannot be established. Unfortunately we did not receive medical information which confirms that the reported injuries were directly caused by disinfectant or are effect of any pre-existing condition. Please note that we don't find these kinds of events (irritations due to use of the disinfectant) to normally be reportable to the competent authorities as it is not likely to cause serious injury or death. However this complaint was decided to be reportable in abundance of caution, as the sustained injury - tumor (indicated by the customer as a result of this event) was assessed as serious. The reported outcomes and the described problem were also assessed by the clinical expert, who concluded that the reported injury is very unlikely to be caused by the reported event, given the indication that the user followed recommendations included in product's ifu. This is supported by our review of past complaints showing this to be an isolated case to date. The reported outcomes can appear only in extreme circumstances such as exposure over many years and/or direct contact with an undiluted solution. Therefore we report this complaint due to the injury, which is most likely not an effect of the reported event, but due to limited information, it is not possible to find the actual root cause. There is no trend with this issue even although there are thousands of these types of baths in the market for well over ten years, and therefore are a vast amount of uses that have taken place to date. The device was not used for patient treatment or care, it was found to be up to specification and it is unclear how it contributed to the event. We continue to monitor the issue and provide additional information in case of new facts become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00155 |
| MDR Report Key | 5832595 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-07-29 |
| Date of Report | 2016-07-11 |
| Date of Event | 2016-07-11 |
| Date Facility Aware | 2016-07-11 |
| Report Date | 2016-09-07 |
| Date Reported to FDA | 2016-09-07 |
| Date Reported to Mfgr | 2016-09-07 |
| Date Mfgr Received | 2016-07-11 |
| Date Added to Maude | 2016-07-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE, STE 308 |
| Manufacturer City | SAN ANTONIO, TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER BATH |
| Generic Name | ILM |
| Product Code | ILM |
| Date Received | 2016-07-29 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-29 |