FDA Adverse Event
Malfunction
Summary report: N
PRISMAFLEX M150
MDR report key: 6094269
·
Received November 10, 2016
Report
- Report Number
- 8010182-2016-00084
- Event Type
- Malfunction
- Date Received
- November 10, 2016
- Date of Event
- October 17, 2016
- Report Date
- November 10, 2016
- Manufacturer
- GAMBRO INDUSTRIES
- Product Code
- KDI
- PMA / PMN Number
- K080519
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A CUSTOMER IN (B)(6) REPORTED THEY HAD A PRISMAFLEX M150 SET THAT WAS FOUND TO HAVE A FLUID LEAK BETWEEN THE DIALYSATE PORT AND TRANSPARENT PLATE DURING A PATIENT TREATMENT. TREATMENT WAS DISCONTINUED AND A PORTION OF THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT. THE AMOUNT OF THE BLOOD LOSS WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 743768 | PRISMAFLEX M150 | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | GAMBRO INDUSTRIES | 115307 | 16C2202GV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PRISMAFLEX (SN:UNKNOWN) |