MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for PRISMAFLO IIS PF2-WP33 manufactured by Stihler Electronic Gmbh.
[136515443]
Based on the investigation is that the heating wire of the heating profile was internally damaged due to external mechanical stress additionally the heating profile was partly covered by patients arm and flank. There is also a strong doubt if the cleaning and disinfecting methods (only with alcohol-based disinfectant agents or ready-to-use disinfectants) for the heating profile were followed correctly (according the instructions for use). The combination of these factors must have lead to the local overheating of the heating profile and consequently to the two burn marks on right arm and flank. The burn marks were small and not judged a serious injury. Because of the characteristics of this event, the manufacturer judges that this event fits in the recall of this product that addresses the potential failure. As soon as the healthcare provider responds to the "urgent medical device correction" form from stihler electronic the affected heating profiles will be replaced.
Patient Sequence No: 1, Text Type: N, H10
[136515444]
It was reported that during continuous renal replacement therapy (crrt) using a blood warmer prismaflo iis, the nurse noticed that the heating profile of the blood warmer was hot and smoking. The patient suffered at least two second degree burns. Treatment was discontinued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617473-2017-00001 |
| MDR Report Key | 8342338 |
| Date Received | 2019-02-15 |
| Date Mfgr Received | 2017-03-01 |
| Date Added to Maude | 2019-02-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL SCHELLING |
| Manufacturer Street | JULIUS-HOELDER-STRASSE 36 |
| Manufacturer City | STUTTGART, 70597 |
| Manufacturer Country | GM |
| Manufacturer Postal | 70597 |
| Manufacturer G1 | STIHLER ELECTRONIC GMBH |
| Manufacturer Street | JULIUS-HOELDER-STRASSE 36 |
| Manufacturer City | STUTTGART, 70597 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 70597 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0759-2019 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRISMAFLO IIS |
| Generic Name | BLOOD WARMER |
| Product Code | KOC |
| Date Received | 2019-02-15 |
| Model Number | PF2-WP33 |
| Catalog Number | PF2-WP33 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STIHLER ELECTRONIC GMBH |
| Manufacturer Address | JULIUS-HOELDER-STRASSE 36 STUTTGART, 70597 GM 70597 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |