FDA Adverse Event
Malfunction
Summary report: N
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
MDR report key: 3072856
·
Received April 23, 2013
Report
- Report Number
- 1416980-2013-10074
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 5, 2013
- Manufacturer
- BAXTER HEALTHCARE - SAO PAULO
- Product Code
- KDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS KNOWN; THEREFORE, A BATCH REVIEW BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4).THIS COMPLAINT IS FOR A CRACKED MINICAP AND THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION, BUT THE LOT NUMBER WAS PROVIDED AND THE BATCH REVIEW FOUND THAT THIS BATCH MET RELEASE REQUIREMENTS.
Description of Event or Problem · 1
A HEALTHCARE PROFESSIONAL CONTACTED THE CUSTOMER SERVICE LINE REPORTING A CRACKED MINI CAP. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173743 | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - SAO PAULO | PS42A6 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TRANSFER SET |