FDA Adverse Event
Injury
Summary report: N
CUSTOM COMBI SET FRES2008 POST
MDR report key: 278099
·
Received May 15, 2000
Report
- Report Number
- 8030665-2000-00150
- Event Type
- Injury
- Date Received
- May 15, 2000
- Date of Event
- April 19, 2000
- Report Date
- April 24, 2000
- Manufacturer
- ERIKA DE REYNOSA
- Product Code
- FJK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ONE OF THREE POSSIBLE PART AND LOT NUMBERS. EITHER 03-222-2 OR 03-2421-0 OR 03-2432-7. THREE EVENTS OCCURRED-TWO AT A FACILITY AND ONE ANOTHER FACILITY. DISCONNECTS FROM QUINTON PERMCATH CATHETERS. THIS EVENT OCCURRED 2.25 HOURS INTO TREATMENT. THE MACHINE DID NOT ALARM. THE CATHETER WAS IMPLANTED APPROXIMATELY 1 YEAR AGO. ESTIMATED BLOOD LOSS 200CC. NO ADD'L ADVERSE EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CUSTOM COMBI SET FRES2008 POST | BLOODLINE | FJK | ERIKA DE REYNOSA | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Other | QUINTON PERMCATH CATHETER. |