MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEDINA SPECTRUM INFUSION PUMP

Catalog Number	35700BAX
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medical/safety review was completed by baxter clinical representatives after reviewing the reported information.The medical/safety review determined it is unlikely that use of the spectrum infusion pump has caused or contributed to the reported event of infiltration.Occlusion-related mechanisms on any infusion pump do not detect or prevent infiltration.Infusion pumps are equipped with downstream occlusion detection mechanisms to identify elevated pressures in the iv administration set between the infusion pump and the patient.When the detection mechanism of the pump identifies an elevated pressure that equals the pump's preset occlusion alarm limits, an audible and visual alarm will be triggered and the iv flow will stop.Infiltration pressure is typically much lower than the pump's downstream occlusion limit, and therefore the occlusion alarm will not be triggered.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a patient experienced infiltration during therapy (medication, dose, programmed amount and delivery rate unknown) while using a spectrum pump in the specialty infusion center.The downstream pressure was reportedly set on the medium setting and pump didn't shut down when patient pressure built up.There was no known patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: the device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPECTRUM INFUSION PUMP
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDINA; medina NY
• MDR Report Key: 8104686
• Report Number: 1314492-2018-04493
• Device Sequence Number: 13475108
• Product Code: FRN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 35700BAX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention