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.
[136496893]
Further investigations are not possible as the defective heating profile was not available for investigation and s/n of defective heating profile was not transmitted. Should additional relevant information become available a supplement report will be submitted. Because of the characteristics of this event the manufacturer judges that this event fits in the recall for this product that addresses this potential failure. As soon as the healthcare provider response to the "urgent medical device correction" form from stihler electronic the affected heating profiles will be replaced. There was no patient injury or medical intervention associated with this event.
Patient Sequence No: 1, Text Type: N, H10
[136496894]
It was reported that during continous renal replacement therapy (crrt) using a prismaflo iis blood warmer the heating profile started smoking and burnt the blood access line. Treatment was discontinued. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617473-2018-00005 |
| MDR Report Key | 8342355 |
| Date Received | 2019-02-15 |
| Date Mfgr Received | 2018-12-20 |
| 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 |