MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP SAPPHIRE SET NV +1.2FLTR; ACCESSORIES, PUMP, INFUSION

Model Number	1632402
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used sapphire primary 1.2-micron filter set clave y-site was received for evaluation.The returned sample was leak tested per product specifications.There was a leak observed from a cut found in the tubing on the inlet tubing port of the filter cassette.The probable cause of this leak cannot be determined.There was also a leak observed from both the inlet and outlet filter.The leak appeared to seep through the filter vent material from various locations.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material.The lot review was performed and there were no issues found.
Event or Problem Description
The customer reported that ndehp sapphire set nv +1.2 filter was leaking.It was further described by the caregiver that tpn was leaking of the filter and blood had refluxed down the tubing all the way to the filter and was also leaking, resulting a patient being soaked in tpn and blood.There were also some large air sections visible closer to the patient than the filter.This occurred 1.5 hours after the iv pump was started.The pump set on 6psi.The pump did not audibly alarm.The patient had to be closely monitored.There is no additional information available.

• Brand Name: NDEHP SAPPHIRE SET NV +1.2FLTR
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9227215
• Report Number: 9615050-2019-00440
• Device Sequence Number: 16746378
• Product Code: MRZ
• UDI-Device Identifier: 10887787007265
• UDI-Public: (01)10887787007265(17)220201(10)3895371
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: 1632402
• Device Catalogue Number: 163240455
• Device Lot Number: 3895371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR