FDA Adverse Event
Malfunction
Summary report: N
COBE CENTRYSYSTEM 3
MDR report key: 133735
·
Received November 22, 1997
Report
- Report Number
- 1713683-1997-00382
- Event Type
- Malfunction
- Date Received
- November 22, 1997
- Report Date
- October 23, 1997
- Manufacturer
- GAMBRO HEALTHCARE
- Product Code
- FII
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GAMBRO HEALTHCARE SERVICE REP WHO REPAIRED THIS MACHINE DID NOT IDENTIFY THIS EVENT AS BEING MDR-REPORTABLE. IT WAS NOT UNTIL A ROUTINE AUDIT BY QA ON 11/21/1997 THAT AN MDR-REPORTABLE EVENT WAS IDENTIFIED. THE MDR WAS THEN FILED. BECAUSE THE EVENT WAS NOT IDENTIFIED BY THE SERVICE REP, NO COMPONENT WAS RETURNED TO THE MFR FOR FAILURE INVESTIGATION. THE SERVICE REP DID, HOWEVER, DETERMINE THE FAILURE MODE IN THE FIELD.
Description of Event or Problem · 1
INSUFFICIENT WEIGHT REMOVAL DUE TO UF (ULTRAFILTRATION) PUMP DIAPHRAGM FAILURE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COBE CENTRYSYSTEM 3 | DIALYSIS CONTROL UNIT | FII | GAMBRO HEALTHCARE | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |