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

Catalog Number 3570009

Device Problems Failure to Sense (1559); Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/08/2023

Event Type  Death  

Manufacturer Narrative

The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a critically ill patient was receiving an infusion of dobutamine (5mcg/kg/min at 11.5 ml/hour flowrate) with a spectrum iq pump.It was further reported the patient was hypotensive and was receiving vasopressin (on another spectrum pump) in addition to the dobutamine ¿to sustain blood pressure¿.The reporter stated the patient was ¿relatively stable¿ and was disconnected from continuous renal replacement therapy for a ct scan.After the ct scan, the patient gradually became hypotensive and was transported back to the intensive care unit where the patient¿s vital signs (blood pressure, heart rate) continued to decline.The physician noted the dobutamine drip was half clamped above the pump.It was unknown how long the line was clamped.According to the reporter, the physician stated, ¿that the acuity of patient's decompensation was more pronounced than would be expected for this decrease in dosage¿.Subsequently, the patient passed away.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Functional testing was performed and did not identify any issues related to the customer reported condition.The device was found to infuse as intended, and when tested for flow accuracy, delivered as intended.In addition, the upstream occlusion test was performed 2 times with passing results.The event history log review revealed that the user experienced two ¿upstream occlusion!¿ alarms during an infusion of dobutamine, which was programmed at the reported rate and on the event date provided by the reporter.The alarms in the log were likely a result of normal pump operation.However, the log only cannot be used to confirm the reported problem.The facility reported that the physician observed a partially closed roller clamp, however it is unknown when the observation was made.It cannot be concluded if the alarms found in the history log were in response to the observed partial occlusion and if an occlusion was cleared or partially cleared at the time of alarm.The upstream occlusion detector may not detect partially occluded tubing or detection may be delayed.A partially occluded line may not allow the proper amount of fluid to be delivered to the patient and can result in an under delivery.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.A device history review revealed no issues that could have caused or contributed to the reported issue.The reported condition was not verified.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 60073 ; 2242702068
• MDR Report Key: 16915604
• MDR Text Key: 315062298
• Report Number: 1314492-2023-01660
• 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: K222048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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: 3570009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: VASOPRESSIN
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Sex: Female