MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2006-10-05 for PRISMAFLEX SYSTEM 6023014700 manufactured by Gambro Lundia Ab, Monitor Div..
[662362]
The customer reported a volume discrepancy. The prismaflex infuses a larger volume without changing the preset parameters. It could not be determined if the volume displayed on the screen was the actual volume infused in the pt (1000 ml within 1 hour). In addition it was observed, that an ultrafiltration rate of 379ml was shown on the screen, although the preset ultrafiltration rate was 0ml. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[7875038]
No serious injury or clinical consequence for the pt was reported. Downloaded event data-file evaluated by a technician at the manufacturing site showed a typical example of a so-called "history jump" (incorrect value displayed). Further investigation has confirmed that untrained personnel were using the prismaflex device, based on knowledge of a similar device, intuition, and not based upon prismaflex training. The user was not opening the scales prior to changing the bag and closing them afterwards; as stated in the prismaflex operator's manual ("changing a bag during treatment"-page 86 ver. 2. Xx), resulting in the incorrect value displayed - "history jump". The user facility will conduct more intensive training for all users. No further action will be taken by gambro renal products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616026-2006-00320 |
| MDR Report Key | 859476 |
| Report Source | 01,05,06 |
| Date Received | 2006-10-05 |
| Date of Report | 2006-09-05 |
| Date of Event | 2006-09-03 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2007-06-05 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANDERS EDNER |
| Manufacturer Street | BOX 10101 |
| Manufacturer City | LUND SE-220 10 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-220 10 |
| Manufacturer Phone | 6169069 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX SYSTEM |
| Generic Name | INTENSIVE CARE HEMODIALYSIS |
| Product Code | KPF |
| Date Received | 2006-10-05 |
| Model Number | 6023014700 |
| Catalog Number | 6023014700 |
| Lot Number | NA |
| ID Number | SW 2.01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 842817 |
| Manufacturer | GAMBRO LUNDIA AB, MONITOR DIV. |
| Manufacturer Address | BOX 10101 LUND SW SE-220 10 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-05 |