MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-10 for SP6000 SP-6000 manufactured by Getinge Disinfection Ab.
[57010058]
(b)(4). Additional information will be provided upon results of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[57010059]
It was reported by the getinge representative that the patient got chemical burn after using the bowl which was previously disinfected in the getinge's device - typhoon. After incident the patient was examined by the doctor who classified the injury as chemical burn. Technical service from the facility stated that the product which they put the night before was getinge clean flusher rinse lot n? 11504.
Patient Sequence No: 1, Text Type: D, B5
[63815385]
An investigation was performed on this complaint. Getinge received a complaint where it was indicated that the patient received chemical burn on her posterior after using a bowl processed in washer disinfector manufactured by the getinge. The product involved in the incident is getinge sp-6000 washer-disinfector. After complaint review for this device we are able to establish that this issue (chemical burn for user/patient) can be considered to be a single, isolated event. (b)(4). Prior the incident occurred the device was used for disinfecting goods. After the process, the goods were taken out from the washer and used by the patient. The most probable root cause of the chemical burn of the patient is the customer (hospital) using a wrong detergent. The material safety data sheet of the mentioned in the complaint description getinge detergent does not contain any possibly dangerous ingredients. Moreover looking at the dilution of the detergent after the process it is considered as not possible that our detergent played a role in the described event. Additionally the customer did not allow getinge representative to investigate and evaluate the device or to take a sample and investigate the detergent, therefore it could be interpret as pointing to a potential user error. It is highly unlikely that the detergent used by the customer is the one which was mentioned and recommended by the getinge and most probably for this reason we have not received any samples for an evaluation. The device was inspected by the customer service manager and as it was stated no malfunction was found that would have played a role in causing the event. Taking under consideration all factors, the most probable root cause of the chemical burn of the patient is customer using wrong detergent. In summary, the device which played a role in this event was used for patient at the time of issue occurrence, due to device's intended use. We have not received any evidence that the getinge device and getinge detergent failed to meet their specification in the way that could be directly involved with the occurrence of the reported incident. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616031-2016-00005 |
| MDR Report Key | 6013477 |
| Date Received | 2016-10-10 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-09-12 |
| Report Date | 2016-10-10 |
| Date Reported to FDA | 2016-10-10 |
| Date Reported to Mfgr | 2016-10-10 |
| Date Mfgr Received | 2016-09-13 |
| Device Manufacturer Date | 2011-09-13 |
| Date Added to Maude | 2016-10-10 |
| 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 | MS ANN WHEELER |
| Manufacturer Street | 1777 E. HENRIETTA ROAD |
| Manufacturer City | ROCHESTER NY 14623 |
| Manufacturer Country | US |
| Manufacturer Postal | 14623 |
| Manufacturer Phone | 5852725036 |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] |
| Manufacturer City | VAXJO, SWEDEN 35115 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 35115 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SP6000 |
| Generic Name | TYPHOON |
| Product Code | FLH |
| Date Received | 2016-10-10 |
| Model Number | SP-6000 |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 VAXJO KRONOBERGS IAN [SE-07] VAXJO, SWEDEN 35115 SW 35115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-10 |