FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 16379313
·
Received February 15, 2023
Report
- Report Number
- 1314492-2023-00408
- Event Type
- Malfunction
- Date Received
- February 15, 2023
- Report Date
- March 23, 2023
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- UDI-DI
- 00085412498683
- PMA / PMN Number
- K133801
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 0
CORRECTED INFORMATION H6: DEVICE PROBLEM CODE A160105 IS CORRECTED TO A160106. ADDITIONAL INFORMATION H3, H6 AND H10: A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A SPECTRUM PUMP FAILED A DOWNSTREAM OCCLUSION POUNDS PER SQUARE INCH TEST IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1126803 | SPECTRUM INFUSION PUMP | PUMP, INFUSION | FRN | BAXTER HEALTHCARE CORPORATION | NA | NA | 00085412498683 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |