MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. GEM NV BLD SET W/180 FLT DEHP-FFP; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10062818
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the gem nv bld set w/180 flt dehp-ffp experienced leakage.The following information was provided by the initial reporter: part#: 10062818.Lot#: 20025359.Issue: after platelets were spiked and advanced into the filter chamber, leakage was noted above the filter on the platelet port.As a result, the unit of platelets were discarded and a replacement unit prepared.Are you able to give a specific time for this instance that happened? no, i do not have the exact time.Can you provide any patient information such as age, weight, diagnosis? no, i cannot provide any patient information as per organization policy.Was the line hooked up to the patient yet before the problem was noticed? yes, the line was hooked up to the patient and the leak was noticed when the platelets were advanced into the filter chamber.Was the line inserted into any pump yet? yes i want to be sure your complaint is about the iv tubing line rather than the filter? the complaint is about the connection between the iv tubing and the filter which is embedded within the line.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of leakage from the filter inlet connection could not be verified due to the product not being returned for failure investigation.The root cause could not be determined without a failure investigation.A device history record review for model 10062818 lot number 20025359 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06feb2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.See h10.
Event or Problem Description
It was reported that the gem nv bld set w/180 flt dehp-ffp experienced leakage.The following information was provided by the initial reporter: part#: 10062818 lot#: 20025359 issue: after platelets were spiked and advanced into the filter chamber, leakage was noted above the filter on the platelet port.As a result, the unit of platelets were discarded and a replacement unit prepared.¿ are you able to give a specific time for this instance that happened? no, i do not have the exact time.¿ can you provide any patient information such as age, weight, diagnosis? no, i cannot provide any patient information as per organization policy.Was the line hooked up to the patient yet before the problem was noticed? yes, the line was hooked up to the patient and the leak was noticed when the platelets were advanced into the filter chamber.¿ was the line inserted into any pump yet? yes ¿ i want to be sure your complaint is about the iv tubing line rather than the filter? the complaint is about the connection between the iv tubing and the filter which is embedded within the line.
Event or Problem Description
It was reported that the gem nv bld set w/180 flt dehp-ffp experienced leakage.The following information was provided by the initial reporter: part#: 10062818; lot#: 20025359.Issue: after platelets were spiked and advanced into the filter chamber, leakage was noted above the filter on the platelet port.As a result, the unit of platelets were discarded and a replacement unit prepared.Are you able to give a specific time for this instance that happened? no, i do not have the exact time.Can you provide any patient information such as age, weight, diagnosis? no, i cannot provide any patient information as per organization policy.Was the line hooked up to the patient yet before the problem was noticed? yes, the line was hooked up to the patient and the leak was noticed when the platelets were advanced into the filter chamber.Was the line inserted into any pump yet? yes.I want to be sure your complaint is about the iv tubing line rather than the filter? the complaint is about the connection between the iv tubing and the filter which is embedded within the line.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 11/17/2020.Investigation conclusion: the customer reported a leak above the filter and returned the affected sample.The sample leaked from the connection in between the two spikes on top of the drip chamber when primed with blue dye water, and the complaint is verified.After the leak was discovered, the tubing was pulled apart without excessive force to investigate the inside of the drip chamber and the tubing.The leaking side of the drip chamber left a residue from the iv fluid that created a ring around the tubing, making it easy to tell the two sides apart.When compared to the other side of tubing, the leaking side appears to have a significantly shorter insertion depth, so that or molding issue are the possible root causes of the failure.A device history record review for model 10062818 lot number 20025359 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06feb2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: GEM NV BLD SET W/180 FLT DEHP-FFP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10564631
• Report Number: 9616066-2020-02857
• Device Sequence Number: 2963621
• Product Code: FPA
• UDI-Device Identifier: 07613203019668
• UDI-Public: 7613203019668
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2020

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: Other
• Device Expiration Date: 02/06/2023
• Device Catalogue Number: 10062818
• Device Lot Number: 20025359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/21/2020; 12/15/2020
• 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: 8015, 8100, 20200825.; 8015, 8100, 20200825.; 8015, 8100, 20200825.
• Outcome Attributed to Adverse Event: Other