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

Catalog Number	20792
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the device had a smoke phenomenon.Testing and investigation confirmed the smoke phenomenon and found that the power supply was burnt and required replacement.There was no patient involvement.No additional information was provided.

• Brand Name: PLUM A + 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: 6827673
• Report Number: 9615050-2017-00094
• Device Sequence Number: 13732434
• Product Code: FRN
• UDI-Device Identifier: M3352079204251
• UDI-Public: +M3352079204251$$+70021664964/16D20160823
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K042081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2017

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: 20792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 08/29/2017
• Patient Sequence Number: 1