MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for PRISMAFLO IIS PF2-WP33 manufactured by Stihler Electronic Gmbh.
[143532490]
The heating device (warming tubing), which was described in the event description, is not a part of the prismaflex dialysis system manufactured by baxter. This device is a blood warmer prismaflo iis 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
[143532491]
It was reported that a nurse noticed the return tube was extremely hot. Upon inspection the nurse found a hole burned in the warming tubing and a burn mark on the return line. The nurse stopped the continous renal replacement therapy (crrt). The nurse notified the dialysis nurse. The prismaflex was switched out with another prismaflex. There was no patient injury or medical intervention associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617473-2019-00002 |
| MDR Report Key | 8554079 |
| Date Received | 2019-04-26 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-04-26 |
| 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. JENS-PETER WEEGE |
| 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 | 2019-04-26 |
| 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 | 2019-04-26 |