FDA Adverse Event
Malfunction
Summary report: N
SABRATEK 6060 HOMERUN PUMP
MDR report key: 735803
·
Received June 24, 2005
Report
- Report Number
- 6000001-2005-02351
- Event Type
- Malfunction
- Date Received
- June 24, 2005
- Date of Event
- April 1, 2005
- Report Date
- June 14, 2005
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
PUMP HAS NOT BEEN RECEIVED FOR EVALUATION. TESTING WAS PERFORMED BY MEDICAL SPECIALTIES AND OVERINFUSION WAS NOT CONFIRMED. PUMP PASSED ALL ACCURACY TESTS PERFORMED BY MEDICAL SPECIALTIES. BAXTER WILL CONTINUE TO INVESTIGATE ANY REPORTS IT RECEIVES AND REVIEW TRENDING OF THESE EVENTS.
Description of Event or Problem · 1
CUSTOMER SENT MEDWATCH TO FDA ON 4/21/2005 #1035274. BAXTER RECEIVED COPY OF MEDWATCH ON 6/14/2005. CUSTOMER REPORTED THE PUMP WAS PROGRAMMED TO DELIVER MEDICATIONS OVER AN 11 HOUR PERIOD. PT RAN OUT OF MEDICATION 1 HOUR PRIOR TO THE TIME IT WAS SUPPOSED TO FINISH (10 HOURS). NO PT INJURY HAS BEEN REPORTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SABRATEK 6060 HOMERUN PUMP | SABRATEK 6060 PUMP | FRN | BAXTER HEALTHCARE (SG) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |