MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. PLUM 360 DRIVER NEW; PUMP INFUSION

Catalog Number	30010
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Emits Odor (1425)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a customer allegation that there was a burnt board and it smelled like burned plastic or an electronic component.During visual inspection, fse testing confirmed burnt components were found on the power supply and determined the probable cause was damage to the power supply board.There were no reports of any adverse patient events or delays in critical therapies, while the device was in clinical use.No additional information was provided.

• Brand Name: PLUM 360 DRIVER NEW
• Common Device Name: PUMP INFUSION
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; 9615050; zona franca global,; la aurora heredia ; CS
• MDR Report Key: 7025789
• Report Number: 9615050-2017-00130
• Device Sequence Number: 11095771
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: +M3353001004051$$+70021774013/16D20161006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 30010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/13/2017
• Patient Sequence Number: 1