FDA Adverse Event
Malfunction
Summary report: N
BULK NON STER XCOAR DELPH PUMP
MDR report key: 4110593
·
Received September 16, 2014
Report
- Report Number
- 1124841-2014-00144
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- August 19, 2014
- Report Date
- August 29, 2014
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- KFM
- PMA / PMN Number
- K112229
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. FOR THIS REASON, (B)(4).
Description of Event or Problem · 1
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CENTRIFUGAL PUMP SQUEALED. NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572166 | BULK NON STER XCOAR DELPH PUMP | CENTRIFUGAL PUMP | KFM | TERUMO CARDIOVASCULAR SYSTEMS CORP. | 3ZZ164275X | RD18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |