FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM IQ INFUSION PUMP
MDR report key: 16475780
·
Received March 2, 2023
Report
- Report Number
- 1314492-2023-00660
- Event Type
- Malfunction
- Date Received
- March 2, 2023
- Date of Event
- January 15, 2023
- Report Date
- June 22, 2023
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- UDI-DI
- 00085412610900
- PMA / PMN Number
- K222048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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
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 IQ PUMP ALARMED UPSTREAM OCCLUSION ALARM AND THE SECONDARY INFUSION DID NOT FLOW DURING CYTARABINE THERAPY AT 192/100 ML. THE PUMP WAS CHANGED OUT AND THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1934925 | SPECTRUM IQ INFUSION PUMP | PUMP, INFUSION | FRN | BAXTER HEALTHCARE CORPORATION | NA | NA | 00085412610900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | CYTARABINE |