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

Catalog Number 1W5000

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an interlink system - solution set incorrectly assembled.During an albumin infusion, a new tubing set was needed.After the tubing was primed, the nurse attempted to insert it into an unspecified infusion pump; however, the set could not be loaded into the pump due to the ¿blue key on the tubing was backwards¿.The albumin was infused by gravity.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed that the fixtured slide clamp component was assembled backward.A functional testing was performed including clear passage and pressure testing; and the device performed according to product specifications.The reported condition was verified during initial inspection.The cause of the condition was due incorrect assembly during the manufacturing process.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 SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11486495
• MDR Text Key: 240343333
• Report Number: 1416980-2021-01331
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412015477
• UDI-Public: (01)00085412015477
• Combination Product (y/n): Y
• PMA/PMN Number: K870940
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1W5000
• Device Lot Number: DR20H13069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALBUMIN; UNSPECIFIED INFUSION PUMP