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

Catalog Number 3570009

Device Problems Filling Problem (1233); Failure to Sense (1559)

Patient Problems Pain (1994); Irritability (2421); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2022

Event Type  Injury  

Event Description

It was reported that a spectrum iq pump was not detecting any occlusions.This occurred during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.During functional testing, the reported problem 'not detecting any occlusions' was reproduced during evaluation.Evaluation found the device passed the downstream occlusion testing and did not alarm for upstream occlusion.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The reported condition was verified.The cause of the condition was determined to be a failed processor board.The processor board requires replacement to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The user facility submitted medwatch (b)(4) for this event.B5: it was reported that during an infusion of fentanyl with a spectrum iq pump, the patient experienced agitation and signs and symptoms of pain.The nurse hung a new bottle of the medication and titrated up several times due to the patient symptoms.The following morning, (approximately eight and half hours later) the nurse observed the bottle of fentanyl was still full and not dripping into the chamber.This was observed over several minutes.The patient outcome was not reported.H10: the device was not evaluated for flow accuracy as additional event details were received after the device had already passed through the entire evaluation process.The device would no longer be in the as received condition, however the device is required to pass all release testing prior to return to the customer.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPECTRUM IQ 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: 13756795
• MDR Text Key: 287112195
• Report Number: 1314492-2022-00886
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412610900
• UDI-Public: (01)00085412610900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3570009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• 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
• Treatment: FENTANYL
• Patient Outcome(s): Other