MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK BURETROL SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C7564

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that air, upstream, and downstream occlusion alarms were triggered on a spectrum pump while being used with unknown quantity of interlink system buretrol solution sets.It was further reported no air or occlusions were noted in the lines.The was observed during use of the sets.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional tests were performed which included pressure test, blockage test and spiking the set into an in-house solution bag and priming it with distilled water following the technique of the user guide with no issues noted.The reported condition was not verified on the companion sample.The actual sample was not received and therefore, could not be evaluated.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK BURETROL SOLUTION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10600439
• MDR Text Key: 208974634
• Report Number: 1416980-2020-06051
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412002781
• UDI-Public: (01)00085412002781
• Combination Product (y/n): Y
• PMA/PMN Number: K123874
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C7564
• Device Lot Number: DR19B16068
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRUM IQ PUMP; SPECTRUM IQ PUMP