MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for PRISMAFLO II PF2-265NA manufactured by Stihler Electronic Gmbh.
[139974252]
The crrt circuit heater, which was described in the event description, is not a part of the prismaflex dialysis system manufactured by gambro (b)(4). This device is a blood warmer prismaflo ii manufactured by stihler electronic as an accessory to prismaflex dialysis system. It is intended to warm the blood return line during prismaflex crrt treatment. Because of the characteristics of this event the manufacturer judges the event fits in the recall for this product that addresses this potential failure. There was no patient injury or medical intervention associated with this event.
Patient Sequence No: 1, Text Type: N, H10
[139974253]
It was reported that a crrt circuit heater malfunctioned and melted a patient's blood return line. Smoke/steam was present. Rn noticed that the circuit warmer hose was hot to touch with blisters on the surface. The crrt needed to be discontinued. Rn notified change immediately. There was no patient injury or medical intervention associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617473-2019-00001 |
| MDR Report Key | 8450977 |
| Date Received | 2019-03-26 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-03-26 |
| 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-0761-2019 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PRISMAFLO II |
| Generic Name | BLOOD WARMER |
| Product Code | KOC |
| Date Received | 2019-03-26 |
| Model Number | PF2-265NA |
| Catalog Number | PF2-265NA |
| 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 | 2019-03-26 |