FDA Adverse Event
Malfunction
Summary report: N
CADD LEGACY PUMP
MDR report key: 14356825
·
Received May 11, 2022
Report
- Report Number
- 3012307300-2022-08512
- Event Type
- Malfunction
- Date Received
- May 11, 2022
- Report Date
- March 6, 2023
- Manufacturer
- ST PAUL
- Product Code
- FRN
- UDI-DI
- 10610586019548
- PMA / PMN Number
- K982838
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
OTHER, OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#(B)(4). A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION SHOWED LABELS WERE INTACT. DURING FUNCTIONAL CHECK, THE REPORTED PROBLEM WAS DUPLICATED. FOUND ERROR CODE 1660 MESSAGES ON THE PUMP DISPLAY AND CLOCK BATTERY WAS OVERDUE. ROOT CAUSE WAS FOUND TO BE A DEFECTIVE MICROPROCESSOR UNIT BOARD AND CLOCK BATTERY. REPLACED MICROPROCESSOR UNIT BOARD AND CLOCK BATTERY.
Description of Event or Problem · 0
IT WAS REPORTED THAT CADD LEGACY PUMP ERROR CODE 1660; CB OVERDUE. NO PATIENT INJURY REPORTED.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 12-MAY-2022. VIA EMAIL FILE CC-0150364 STATING THAT EVENT DID NOT OCCUR WHILE IN USE BY PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693302 | CADD LEGACY PUMP | PUMP, INFUSION | FRN | ST PAUL | 21-6400-51 | 10610586019548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |