MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPECTRUM INFUSION PUMP; PUMP, INFUSION

Catalog Number 35700BAX2

Device Problems False Alarm (1013); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

It was reported that a spectrum pump was running, there were no occlusions alarms, yet there was no flow out of the bag or in the drip chamber.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The device was found within specification and the customer reported issue 'despite there being no flow out of the bag or in the drip chamber' could not be reproduced during evaluation.The reported condition was not verified.Troubleshooting the device revealed no hardware/software abnormalities that would induce the reported allegation.No correction is required.Should additional relevant information become available, a supplemental report will be submitted.The device was received for evaluation.During functional testing, the reported problem 'nursing staff reported that pump was running, with no occlusion alarms' was reproduced during evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.Evaluation observed and found that the pump did not alarm for the upstream occlusion when the tube set was manually clamped.The cause of the condition was determined to be a failed processor printed circuit board (pcb).The processor pcb requires replacement to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPECTRUM INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDINA; 711 park ave; medina NY 14103
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13901851
• MDR Text Key: 288180297
• Report Number: 1314492-2022-01093
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412498683
• UDI-Public: (01)00085412498683
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 35700BAX2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2022
• 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