MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for PRISMAFLO II PF2-WP2618 manufactured by Stihler Electronic Gmbh.
[137008436]
Further investigations are not possible as the defective device was not available for investigation. From the venet description the device reacted with an alarm and heater cut off as intended. Should additional relevant information become available a supplement report will be submitted. There was no patient injury or medical intervention associated with this event.
Patient Sequence No: 1, Text Type: N, H10
[137008437]
It was reported that during continuous renal replacement therapy (crrt) using a blood warmer prismaflo ii did not heating up as it should and error message on the screen showed "e". There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617473-2016-00002 |
| MDR Report Key | 8342339 |
| Date Received | 2019-02-15 |
| Date Mfgr Received | 2016-08-12 |
| 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 | 3 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRISMAFLO II |
| Generic Name | BLOOD WARMER |
| Product Code | KOC |
| Date Received | 2019-02-15 |
| Model Number | PF2-WP2618 |
| Catalog Number | PF2-WP2618 |
| 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 |