MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM A+ DRIVER NEW 802.11 ABG V.13.4; PUMP, INFUSION

Model Number	2079225
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return for evaluation.It has not been received.
Event or Problem Description
The event involved a plum a+ pump that was reported to be over infusing and did not audibly alarm for air in line.The device was reported to deliver 50 mls faster than it should have.No additional information has been provided.
Additional Manufacturer Narrative
H10 - the device was not returned for investigation.The customers complaint could not be confirmed as the device in question was not returned for physical investigation.A 12 month service history review did not show any similar cases.Additional information can be found in sections d1, d4 - catalog no, serial no, unique identifier (udi) #, d10 and h4.

• Brand Name: PLUM A+ DRIVER NEW 802.11 ABG V.13.4
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9449724
• Report Number: 9615050-2019-00468
• Device Sequence Number: 2090558
• Product Code: FRN
• UDI-Device Identifier: M3352079204251
• UDI-Public: M3352079204251
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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 Model Number: 2079225
• Device Catalogue Number: 207920481
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 03/13/2020
• Patient Sequence Number: 1