MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION ADMINISTRATION SETS

Catalog Number 2C8571

Device Problems Improper Flow or Infusion (2954); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported air bubbles were observed in a clearlink system continu-flo solution set.It further reported that there was a tendency in producing foam and small air bubbles during infusion of etoposide.This resulted in the spectrum pump alarming air in the line.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h4 and h6.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK CONTINU-FLO SOLUTION ADMINISTRATION SETS
• Type of Device: CLEARLINK CONTINU-FLO SOLUTION ADMINISTRATION SETS
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10616571
• MDR Text Key: 209559343
• Report Number: 1416980-2020-06102
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412046327
• UDI-Public: (01)00085412046327
• Combination Product (y/n): Y
• PMA/PMN Number: K153158
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8571
• Device Lot Number: R20D27076
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ETOPOSIDE; SPECTRUM INFUSION IQ PUMP