MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number AM3090

Device Problems Break (1069); Crack (1135); Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation, however, investigation is not yet complete.

Event Description

The event occurred on an unspecified date and involved a 10" ext set w/3-port nanoclave® manifold, check valve, clamp, luer lock.The customer reported that they had an issue wherein a port on the manifonifold was broken and caused medication (vasporessors) to not be delivered as intended to the patient; the patient's blood pressure dropped (systolic in the 70s and mean arterial pressure was in the 40s).There was a delay in therapy as the vasopressor medications were running through this port and were not reaching patient since they were leaking out of the broken seam.The intervention was rearranging the infusion to a different delivery system.There was patient involvement, but harm was not reported as a consequence of this event.

Manufacturer Narrative

One (1) used sample #(b)(6) was returned for evaluation.As received one of the nano manifold clave was observed to be broken off from manifold base.The missing nano manifold clave was not returned for evaluation.It was confirmed from the broken nanoclave an insufficient adhesive applied.The 2 nanoclave left were torque tested and they met product specification.The complaint of leaks can be confirmed based on the used physical sample evaluation.The probable cause was due to insufficient adhesive applied during manual process assembly during manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 10" EXT SET W/3-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, CLAMP, LUER LOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18412798
• MDR Text Key: 331599522
• Report Number: 9617594-2023-01204
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709080799
• UDI-Public: (01)00887709080799(17)280501(10)13635217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AM3090
• Device Lot Number: 13635217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VASOPRESSOR MEDICATION, MFR UNK.