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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MEDINA SPECTRUM INFUSION PUMP Back to Search Results
Catalog Number 35700BAX
Device Problem Defective Alarm
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.

 
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Brand NameSPECTRUM INFUSION PUMP
Type of DeviceINFUSION 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 Key8104686
Report Number1314492-2018-04493
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 12/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number35700BAX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
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 TREATMENT DATA
Date Received: 11/26/2018 Patient Sequence Number: 1
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