FDA Adverse Event
Malfunction
Summary report: N
ACCUSOL
MDR report key: 4221353
·
Received November 3, 2014
Report
- Report Number
- 1416980-2014-38500
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- September 22, 2014
- Report Date
- October 7, 2014
- Manufacturer
- BAXTER HEALTHCARE - CASTLEBAR
- Product Code
- KPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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 · 1
IT WAS REPORTED THAT THE BLUE CAPSULE ON AN ACCUSOL DEVICE WAS MISSING. THIS WAS FOUND WHEN ADDING IONS TO THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701860 | ACCUSOL | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) | KPO | BAXTER HEALTHCARE - CASTLEBAR | 14F19G73 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |