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

Catalog Number	30010
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not complete.
Event or Problem Description
The event involved a customer allegation of a device with a scorched ground prong on the ac cord.There was no patient involvement and no reports of any adverse patient events or delays in critical therapies while the device was in clinical use.No additional information was provided.
Additional Manufacturer Narrative
Testing and investigation found that the ground prong on the ac cord is charred/scorched.The ac cord was plugged into an ac outlet, the ac icon on the device turned on and the device turned on using ac.There was no sparks, burning, or smoke observed.The ac plug was removed and no smells associated with charring/scorching were observed.The electrical issues could not be duplicated and no probable cause could be determined.
Event or Problem Description
The event involved a customer allegation of a device with a scorched ground prong on the ac cord.There was no patient involvement and no reports of any adverse patient events or delays in critical therapies while the device was in clinical use.No additional information was provided.Follow-up 1: testing and investigation found that the ground prong on the ac cord is charred/scorched.The ac cord was plugged into an ac outlet, the ac icon on the device turned on and the device turned on using ac.There was no sparks, burning, or smoke observed.The ac plug was removed and no smells associated with charring/scorching were observed.The electrical issues could not be duplicated and no probable cause could be determined.

• 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: 7124514
• Report Number: 9615050-2017-00148
• Device Sequence Number: 1799194
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: +M3353001004051$$+70021786779/16D20170607
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2017

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: 12/13/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/08/2018
• Patient Sequence Number: 1