MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-22 for ORS-320 SLUSH WARMER DISC DRAPE manufactured by Microtek Dominicana, S.a..
[93299875]
No samples were returned for this investigation. The dhr was reviewed for this lot and it was noticed that (b)(4) cases were manufactured from 07/04/2017 to 07/09/2017. No defects were reported during quality inspection. Based on the dhr review this does not appear to be the result of a personnel, process or material issue. Melts, though uncommon, can occur when the warmer is not draped properly, not turned off by using the power button, and/or there is insufficient fluid in the warmer basin, contrary to the operations manual, product labeling, product insert and in-service presentations. Because no sample was provided and the non conformance could not be confirmed, no additional actions will be taken at this time. If additional information becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[93299876]
End user reported " we are unsure if the leak was due to the drape, or the machine malfunctioning. We bagged the drape and sent it for inspection, and reported the machine involved. This has happened mulitple times already. The consequences could be very serious for the patient in terms of infection. We could be irrigating the patient's heart with unsterile fluid. " no patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2017-00031 |
| MDR Report Key | 7052791 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-22 |
| Date of Report | 2017-10-24 |
| Date Mfgr Received | 2017-10-24 |
| Date Added to Maude | 2017-11-22 |
| 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 JENNIFER MRKVICKA |
| Manufacturer Street | 1 ECOLAB PLACE |
| Manufacturer City | ST. PAUL MN 55102 |
| Manufacturer Country | US |
| Manufacturer Postal | 55102 |
| Manufacturer Phone | 6512502237 |
| Manufacturer G1 | MICROTEK DOMINICANA |
| Manufacturer Street | ZONA FRANCA NO. 2 |
| Manufacturer City | LA ROMANA, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORS-320 SLUSH WARMER DISC DRAPE |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2017-11-22 |
| Model Number | ORS-320 |
| Lot Number | D171841 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK DOMINICANA, S.A. |
| Manufacturer Address | ZONA FRANCA NO. 2 LA ROMANA, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-22 |