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 Awareness during Anaesthesia (1707); High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.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 device was found out of specification in relation to the customer reported "did not alarm an upstream occlusion" which was not reproduced.The cause was determined to be an out of specification ultrasonic sensor.The reported condition was verified.The ultrasonic sensor was replaced to correct this condition.An event history log found no significant evidence to support the customer-reported allegation of "was not infusing".The device was not investigated in relation to the reported 'was not infusing' allegation, it cannot be confirmed that this issue was addressed, the device will undergo full release testing prior to return to customer to ensure proper working condition of the pump.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a spectrum pump was not infusing and did not generate an upstream occlusion alarm during therapy.It was reported that a high blood pressure alarm was triggered by the monitor and the patient was observed to be restless (constantly moving, seems uncomfortable).It was reported that approximately 1-2 minutes later after being assessed as stable, the patient was violently agitated requiring constant bedside monitoring (to prevent extubation).It was reported that the propofol pathway was ¿quite permeable¿ and upon inspection of the tubing, it was observed that the tubing was folded just under the dropper chamber and the tubing was filled.The tubing was released from the pump and it was observed to have collapsed with almost no liquid in the lumen, despite the pump indicating that the infusion was in progress.It was also observed that there was sufficient propofol left in the bottle to ensure continuous infusion.The tubing was then repositioned in the pump by stiffening it and the drip chamber was emptied to ensure visibility of the flow.It was reported that the patient recovered.No additional information is available.

Manufacturer Narrative

Corrected information h6: the device code 1403 has been added to address the reported "was not infusing".The investigation findings code c070602 has been updated to c0402.B5: additional information was received stating the reported event occurred during propofol (100 ml) infusion at 20ml/ hr.The patient's blood pressure became superior to 180 mmhg and was lower than 140 mmhg before the issue with the pump.It was mentioned that the occlusion setting was set by the biomedical team and are set to medium.In general they do not touch these parameters, but they cannot confirm if the parameters were changed.It was unknown if auto restart was enabled or disabled from the drug library.No additional information is available.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
• MDR Report Key: 12397386
• MDR Text Key: 269330233
• Report Number: 1314492-2021-03223
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412610900
• UDI-Public: (01)00085412610900
• Combination Product (y/n): Y
• PMA/PMN Number: K173084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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: 08/06/2021
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR