FDA Adverse Event
Injury
Summary report: N
NXSTAGE SYSTEM ONE
MDR report key: 1924799
·
Received December 7, 2010
Report
- Report Number
- 3003464075-2010-00129
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- October 22, 2010
- Report Date
- November 8, 2010
- Manufacturer
- NXSTAGE MEDICAL, INC.
- Product Code
- KDI
- PMA / PMN Number
- K050525
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO INVESTIGATION IS POSSIBLE WITHOUT THE RETURNED PRODUCT OR LOT NUMBER INFO; THEREFORE, THE EXACT CAUSE OF THE BROKEN LUER TIP CANNOT BE DETERMINED. STANDARD INDUSTRY LUER COMPONENTS ARE USED IN THE CARTRIDGE ASSEMBLY. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.
Description of Event or Problem · 1
FOLLOWING THE COMPLETION OF A CRRT TREATMENT, THE MALE LUER TIP OF ONE OF THE BLOOD LINES BROKE OFF IN THE PT'S ACCESS WHEN DISCONNECTING THE CARTRIDGE LINE FROM THE ACCESS. NO PROBLEM WAS NOTED WHEN THE INITIAL CONNECTION WAS MADE. THE VASCATH ACCESS HAD TO BE REPLACED. NO ADD'L MEDICAL INTERVENTION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NXSTAGE SYSTEM ONE | HIGH PERMEABILITY HEMODIALYSIS SYSTEM | KDI | NXSTAGE MEDICAL, INC. | CAR-505 | 0077802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |