FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM IQI NFUSION PUMP
MDR report key: 11349917
·
Received February 19, 2021
Report
- Report Number
- 1314492-2021-00472
- Event Type
- Malfunction
- Date Received
- February 19, 2021
- Report Date
- March 19, 2021
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- UDI-DI
- 00085412610900
- PMA / PMN Number
- K173084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION H3, H6 AND H10: 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 Manufacturer Narrative · 1
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP WAS BEEPING NONSTOP AND DISPLAYED 'AMX ERROR. ERR: OXFFFFFFFF (CJ_ERCCC) TSK: 0X48020C18 (UNKNOWN) SYS ECODE: 0; ;)'. THERE WAS PATIENT INVOLVEMENT BUT NO KNOWN 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 |
|---|---|---|---|---|---|---|---|
| 246686 | SPECTRUM IQI NFUSION PUMP | PUMP , INFUSION | FRN | BAXTER HEALTHCARE CORPORATION | NA | NA | 00085412610900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |