MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, UNIV ENDS,; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number H93821

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that four (4) fluid transfer tube sets were leaking.This event occurred during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured between april 07, 2022 and april 08, 2022.H10: two (2) actual devices were received for evaluation.The remaining 2 samples were not received, therefore a device analysis could not be completed for those samples.Unaided visual inspection using the naked eye along with magnification was performed on the returned samples which identified a tear/hole at a damaged area (midsection) of the silicone tubing of both tube sets.A repeater pump system level testing was performed which revealed a leak from the impacted areas.The reported condition was verified on the returned samples.The cause of the damage could not be determined; however a probable cause is due to customer handling during setup causing damage to the section of tubing from the repeater pump rotor.Instructions for use does state to¿move the rotor back and forth several times to make sure that it moves freely.¿ a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TUBE SET, STD VOL, UNIV ENDS,
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16765371
• MDR Text Key: 313538969
• Report Number: 1416980-2023-01835
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412476520
• UDI-Public: (01)00085412476520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H93821
• Device Lot Number: 60359403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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