MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C8612
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during patient infusion of phenylephrine with a clearlink extension set, a leak occurred due to ¿broken apart¿ tubing.The location of the separation was specified as ¿where the y sites meet the tubing, the seam broke apart¿.The cause was not reported.It was reported one end of the tubing that was still connected to the patient¿s line was ¿back flowing filling¿ with blood which resulted in an estimated blood loss of less than 100ml.The hemoglobin level before and after the event was reported as stable and no blood transfusion was required.It was reported the ¿broken apart¿ tubing delayed the delivery of the medication infusion, which resulted in a blood pressure drop to ¿80s/40s¿.Prior to the delay, the blood pressure reading was ¿110¿s/70¿s¿.It was reported the patient was stable and did not require intervention.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.During visual inspection, the tubing was observed separated from the first y-site clearlink in the downstream part.It was further revealed there was excess solvent in the circumference of the tubing.The reported condition was verified.The cause of the event was due to excess solvent from an incorrect execution of the assembly method by the solvent dispenser.A nonconformance has been opened to address this issue.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 LUER ACTIVATED VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11436946
• Report Number: 1416980-2021-01117
• Device Sequence Number: 4611294
• Product Code: FPA
• UDI-Device Identifier: 00085412070056
• UDI-Public: (01)00085412070056
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2025
• Device Catalogue Number: 2C8612
• Device Lot Number: R20J27082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRUM PUMP; SPECTRUM PUMP
• Outcome Attributed to Adverse Event: Other