FDA Adverse Event
Injury
Summary report: N
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
MDR report key: 1790343
·
Received August 10, 2010
Report
- Report Number
- 1423500-2010-02322
- Event Type
- Injury
- Date Received
- August 10, 2010
- Date of Event
- July 11, 2010
- Report Date
- July 11, 2010
- Manufacturer
- BAXTER HEALTHCARE - CLEVELAND
- Product Code
- KDI
- PMA / PMN Number
- K895631
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SAMPLE NOT AVAILABLE AS PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY.
Description of Event or Problem · 1
ON (B)(6) 2010 PRODUCT SURVEILLANCE CONTACTED PERITONEAL DIALYSIS (PD) NURSE REGARDING THE LOW DRAIN VOLUME ALARM. THE NURSE STATED THAT THE HOMECHOICE PATIENT WAS IN THE HOSPITAL LAST WEEK DUE TO PERITONITIS. DATE OF PERITONITIS WAS (B)(6) 2010. PATIENT WAS HOSPITALIZED FROM (B)(6) 2010 TO (B)(6) 2010. PATIENT WAS TREATED WITH TWO GRAMS OF INTRAPERITONEAL ANTIBIOTICS. THE PD NURSE STATED THE CAUSE OF PERITONITIS WAS UNKNOWN, THAT IT WAS NOT RELATED TO ANY BAXTER PRODUCTS OR SOLUTIONS. THE PATIENT HAS RECOVERED FROM THE PERITONITIS. THIS IS COMPLAINT TWO OF FIVE RELATED COMPLAINTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINI-CAP, DISCONNECT W/PVP-1SOLUTION | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - CLEVELAND | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| R | THERAPY (B)(4) 1.5% LO/CAL 6L/6L DNL (B)(4) 2.5% L |