MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8541

Device Problem Fluid/Blood Leak (1250)

Patient Problem Injury (2348)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Device manufacturer address: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient was administered an epidural while receiving unspecified intravenous (iv) fluids with use of a clearlink duo-vent set.It was reported 15 minutes later; the fetal heart rate (fhr) was observed to go into late decelerations.The patient was turned to the right and left side.The iv bolus continued and seven minutes later the fhr went into ¿prolonged deceleration¿.The nurse observed the iv fluid leaking onto the floor.It was reported that the iv bolus tubing was severed at the multiport site, specified as ¿broken in the middle¿.The set was changed, and a bolus of unspecified medication was administered.The patient outcome was reported as the fhr "recovered".No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection with the naked eye was performed and no leak, cut or slice was observed.Pressure and clear passage underwater testing were performed with no issues noted.It was observed that the male luer rigid component was cracked and a trace of external force was applied to the component, making an appearance of a white color.The sample was used, therefore, the male luer was not damaged at the beginning of treatment.The reported condition of leak was not verified.The cause of the condition could not be determined; however, a potential cause could be not conforming material and damage in 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: CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10848254
• MDR Text Key: 216831268
• Report Number: 1416980-2020-07156
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412071107
• UDI-Public: (01)00085412071107
• Combination Product (y/n): Y
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8541
• Device Lot Number: R20B18079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention