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 OR PRISMAFLO IIS NO INFORMATION manufactured by Stihler Electronic Gmbh.
[136520766]
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 of this product that addresses the potential failure. The indication that pca was "sapped" is not possible as the applied part of product is classified "cf". As soon as the healthcare provider responds to the "urgent medical device correction" form from stihler electronic the affected heating profile will be replaced. There was no patient injury or medical intervention associated with this event.
Patient Sequence No: 1, Text Type: N, H10
[136520767]
It was reported that during continous renal replacement therapy (crrt) using a blood warmer (prsimaflo ii or prismaflo iis). The user noticed a small bubble on the surface of the heating profile. The bubble was glowing red and issuing a small amount of smoke. Treatment was discontinued. 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 | 9617473-2018-00003 |
| MDR Report Key | 8342353 |
| Date Received | 2019-02-15 |
| Date Mfgr Received | 2018-06-07 |
| 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-HOELER-STRASSE 36 |
| Manufacturer City | STUTTGART, 70597 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 70597 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRISMAFLO II OR PRISMAFLO IIS |
| Generic Name | BLOOD WARMER |
| Product Code | KOC |
| Date Received | 2019-02-15 |
| Model Number | NO INFORMATION |
| Catalog Number | NO INFORMATION |
| 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 |