MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,W/WATER TRAPS,LON; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 1615

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One (1) 1615 ventilator tubing set, w/water traps, long, was received for investigation.The ventilator tubing set was visually inspected for any signs of abuse/misuse/damage.Nothing was noted.The dual limb 1615 ventilator tubing set, w/water traps, long was setup for leak test on a lab leak tester.Per iso standard 5367 annex e, the ventilator tubing set was tested at 60 +/- 3 cmh2o of pressure with incoming equipment pressure set a 30 psi.The acceptable leak value is = 30 ml/min.The actual ml/min pressure recorded was at least +80ml/min.The 1615 ventilator tubing set is leaking beyond the specified range , established in the iso acceptable parameters.The device history record of batch number 74k1801241 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the investigation performed, the reported complaint has been confirmed.Based on magnified visual inspection, it appears as though a sharp object came in contact with the blue tubing resulting in a sliced rib.Gas leakage cannot be measured due to the profuse volume of gas escaping.This product is inspected and tested 100% at the manufacturing site for leakage and any other physical damage noted.The dhr review did not uncover any manufacturing anomalies; therefore, it was determined that the incident is not manufacturing related.An actual root cause could not be established.

Event Description

Customer complaint states: "rt attempted ventilator sst (short self test) and it failed the leak test." alleged issue reported as occurred during pre-testing prior to a patient use.No patient involvement reported.

• Brand Name: HUDSON VENTILATOR TUBING SET,W/WATER TRAPS,LON
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 8600262
• MDR Text Key: 144728234
• Report Number: 3004365956-2019-00124
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1615
• Device Lot Number: 74K1801241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2018
• 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: NONE REPORTED.