FDA Adverse Event
Malfunction
Summary report: N
CASSETTE MEDI RESERVOIR
MDR report key: 10875475
·
Received November 19, 2020
Report
- Report Number
- MW5098000
- Event Type
- Malfunction
- Date Received
- November 19, 2020
- Report Date
- November 16, 2020
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
SPONTANEOUS CALL FROM PATIENT STATING A VELETRI CASSETTE THE TUBING "FELL OUT OF THE TRACK" ON TOP AND PREVENTS FROM ATTACHING TO THE PUMP, PATIENT ATTACHED ANOTHER CASSETTE WITHOUT ISSUE. STATED THIS HAPPENED ONCE LAST MONTH AS WELL. THIS CASSETTE LOT 3983323. PATIENT HAS CASSETTE FOR RETURN TO MANUFACTURE IF REQUESTED. CASSETTE WAS NOT IN USE WHEN FAULT OCCURRED. NO LAPSE IN INFUSION OR SIDE EFFECTS DUE TO MALFUNCTION. SENDING REPLACEMENT CASSETTES WITH NEXT REFILL. PATIENT DOES HAVE BACK UP CASSETTE AND SUCCESSFULLY CONTINUED THEIR INFUSION. INFUSION IS LIFE-SUSTAINING. OUTCOME-RESOLVED. REPORTED BY (B)(6) BY: PATIENT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1338034 | CASSETTE MEDI RESERVOIR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL ASD, INC. | 3983323 | ||
| 1338035 | CASSETTE MEDI RESERVOIR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL ASD, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |