FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR PUMP PAIN MA
MDR report key: 4152577
·
Received October 6, 2014
Report
- Report Number
- 9615050-2014-05501
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Date of Event
- August 28, 2014
- Report Date
- September 3, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K083019
- Removal / Correction Number
- Z-1170-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING TESTING AT THE SERVICE CENTER CORROSION WAS NOTED IN THE BATTERY COMPARTMENT OF THE DEVICE. THIS WAS DUE TO BATTERY LEAKAGE FROM THE DISPOSABLE BATTERIES. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE ALARMED WITH AN UNSPECIFIED ALARM CODE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, LEAKAGE FROM THE DISPOSABLE BATTERIES WAS NOTED IN THE BATTERY COMPARTMENT OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622204 | GEMSTAR PUMP PAIN MA | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |