SPECTRUM IQ INFUSION PUMP
Report
- Report Number
- 1314492-2022-01033
- Event Type
- Malfunction
- Date Received
- March 23, 2022
- Date of Event
- February 11, 2022
- Report Date
- June 21, 2022
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- UDI-DI
- 00085412610900
- PMA / PMN Number
- K173084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
H3, H6 AND H10: A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE 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.
ADDITIONAL INFORMATION/CORRECTION: B5 - IT WAS REPORTED THAT A SPECTRUM PUMP ALSO FAILED TO DETECT A DOWNSTREAM OCCLUSION DURING TESTING. CORRECTED INFORMATION E1 INITIAL REPORTER FIRST NAME:(B)(6). CORRECTED INFORMATION G4 PMA/510K # OR BLA #: K220417. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT A SPECTRUM IQ PUMP HAD UNDETECTED UPSTREAM OCCLUSION DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1069998 | SPECTRUM IQ INFUSION PUMP | PUMP, INFUSION | FRN | BAXTER HEALTHCARE CORPORATION | NA | NA | 00085412610900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |