MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PCA ASV MICROBORE; INTRAVASCULAR ADMINISTRATION SET

Model Number	30883
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2020
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 pca asv microbore tubing would not flush.The following information was provided by the initial reporter: "tubing will not flush.".
Event or Problem Description
It was reported that the pca asv microbore tubing would not flush.The following information was provided by the initial reporter: "tubing will not flush.".
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint that the tubing will not flush could not be verified due to the product not being returned for failure investigation.A device history record review for model 30883 lot number 20076403 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - fluid blockage with lot #20076403 regarding item #30883.

• Brand Name: PCA ASV MICROBORE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 11182501
• Report Number: 9616066-2021-50071
• Device Sequence Number: 19581820
• Product Code: FPA
• UDI-Device Identifier: 50885403273955
• UDI-Public: 50885403273955
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 07/11/2023
• Device Model Number: 30883
• Device Catalogue Number: 30883
• Device Lot Number: 20076403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1