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

Catalog Number 3570009

Device Problem Infusion or Flow Problem (2964)

Patient Problem Electrolyte Imbalance (2196)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a spectrum iq pump had a flow issue during the infusion of citrate (50 ml/h) resulting in a marked decrease in bicarbonate which led to metabolic acidosis and haemodynamic instability with high flow-rate amine requirements.Continuous veno-venous haemofiltration therapy with citrate and calcium infusions were stopped.The patient was treated with calcium chloride solution and bicarbonate solution (stat ).Patient outcome was not reported.No additional information is available.

Manufacturer Narrative

G4 pma/510k # or bla #: k220417.The device was received for evaluation.During functional testing, 'infusion problem' was unable to be reproduced.Evaluation performed flow accuracy testing with passing results with errors of 0.43% and 0.90% which are within specification.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.No correction is required.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: 14499473
• MDR Text Key: 292706931
• Report Number: 1314492-2022-02088
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• 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: 06/17/2022
• 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: CITRATE; SET JC8386
• Patient Outcome(s): Required Intervention