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); Battery Problem (2885)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.
Event or Problem Description
The customer reported that the device battery overheated, there was a hole in the battery, and it was hot enough that the bottom of the case and battery door burnt.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.
Additional Manufacturer Narrative
Testing and investigation found that during visual inspection, the battery was noted to be swollen and the battery door pad was melted (not battery door).The customer's complaint was confirmed and the probable cause was found to be due to a defective battery.
Event or Problem Description
The customer reported that the device battery overheated, there was a hole in the battery, and it was hot enough that the bottom of the case and battery door burnt.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: 7373581
• Report Number: 9615050-2018-00032
• Device Sequence Number: 1055573
• Product Code: FRN
• UDI-Device Identifier: M3353001004051
• UDI-Public: +M3353001004051$$+70021784255/16D20170518
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/20/2018

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: 04/04/2018
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/19/2018
• Patient Sequence Number: 1