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

Catalog Number 35700BAX

Device Problem Defective Alarm (1014)

Patient Problem Inflammation (1932)

Event Date 11/01/2018

Event Type  malfunction  

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 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.

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
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDINA; medina NY
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDINA; 711 park ave; medina NY 14103
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8104686
• MDR Text Key: 128388059
• Report Number: 1314492-2018-04493
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 35700BAX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention