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

Catalog Number 3570009

Device Problem Intermittent Loss of Power (4016)

Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 08/29/2022

Event Type  Injury  

Event Description

It was reported that during patient infusion of levophed ¿8 in 250 running at 80cc¿ with a spectrum iq pump, the pump indicated a low battery while connected directly to the power outlet in the wall.It was further reported by the time the nurse ¿reinstalled a new pump rod¿ the pump shut off.The infusion was re-started, and the patient's blood pressure (bp) dropped to 71/31, "tam" 47.According to the reporter the "ta" 268/98 patient with esv and arrhythmia".The sequence of the events is not clear from the reported information.Treatment and patient outcome were not reported.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.Functional testing was performed and did not identify any issues related to the customer reported condition.Evaluation observed and found no issues was found during the evaluation and customer battery was not returned for evaluation, and the pump had no depressed battery pins or contaminations on the pins, and no alternating current power adapter failure, and pump rear case functioned normally with no issue, and there was no fluid intrusion.Troubleshooting the device revealed no hardware or software abnormalities that would induce the reported allegation.A review of the event history log revealed the pump shuts off' could not be confirmed.A device 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 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 ; 2242702068
• MDR Report Key: 15528928
• MDR Text Key: 301027946
• Report Number: 1314492-2022-04240
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412610900
• UDI-Public: (01)00085412610900
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K220417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• 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: LEVOPHED
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male