FDA Adverse Event
Malfunction
Summary report: N
ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM
MDR report key: 2121908
·
Received May 23, 2011
Report
- Report Number
- 1219343-2011-00033
- Event Type
- Malfunction
- Date Received
- May 23, 2011
- Date of Event
- April 25, 2011
- Report Date
- May 23, 2011
- Manufacturer
- HAEMONETICS CORP.
- Product Code
- CAC
- PMA / PMN Number
- K992723
- Removal / Correction Number
- 1219343-04/29/2011-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER(S) RETURNED THE ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM FOR REPAIR DUE TO FLUID INGRESS. FLUID INGRESS RESULTED IN ELECTRONIC FAILURE DUE TO SHORT CIRCUIT. NO PT OR OPERATOR INJURY WAS NOTED IN THE SVC/COMPLAINT RECORDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM | PERIOPERATIVE AUTOTRANSFUSION SYSTEM | CAC | HAEMONETICS CORP. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |