FDA Adverse Event
Malfunction
Summary report: N
AUTOCAT2 WAVE
MDR report key: 1070052
·
Received July 3, 2008
Report
- Report Number
- 1219856-2008-00313
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 21, 2008
- Report Date
- July 3, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K021462
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CALL WAS PLACED TO HOT LINE DETAILING THE FOLLOWING: REGISTERED NURSE (RN) IN CATH LAB STATED PUMP IS "LEAKING HELIUM AT TANK CONNECTION TO THE PUMP." RN ALSO TOLD CLINICAL SUPPORT SPECIALIST (CSS) THAT TANK HAD BEEN CHANGED BY PERFUSION & RN COULD HEAR IT LEAK. "THEY USE DISPOSABLE TANKS." CSS ASKED RN TO CHECK & CHANGE WASHER AT D RING CONNECTION. RN SAID SHE COULD STILL HEAR IT LEAK. CSS ASKED RN TO DOUBLE CHECK CONNECTION ALIGNMENT. RN STATED "IT HAS ALIGNED PROPERLY AND CONNECTED SECURELY. RN DESCRIBED THE SOUND AS COMING FROM THE BACK OF THE TANK IN THE PUMP." CSS REQUESTED THAT RN TAKE PUMP OUT OF SERVICE AND SEND TO BIO-MED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOCAT2 WAVE | INTRA-AORTIC BALLOON PUMP PRODUCTS | DSP | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |