MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP; SET, I.V. FLUID TRANSFER

Catalog Number E1302OD

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that particulate matter (pm) was observed within a 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag.The pm was further described as needle-shaped, long, thin, and transparent particle of approximately 0.5 cm in length which appeared to be a film residue.The bag was filled with a volume of 250 ml (potassium chloride 1 molar solution 30 ml, magnesium aspartate solution 0.5 molar 14.85 ml, water for injections 205.15 ml).The issue was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection was performed and the presence of a particle inside the bag was observed.The solution was filtered on a membrane; thus it was possible to isolate a thin translucent filament, which was approximately 4mm long.Through ftir (fourier-transform infrared spectroscopy) the material was identified as pmma (polymethyl methacrylate).This material is not used in the manufacture of the bag, therefore, it's source was unknown.The reported condition was verified.The cause of the condition could not be determined.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): TP - B.BRAUN AVITUM ITALY S.P.A. - SP006457; via xxv luglio 11; mirandola (mo) ; IT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16421569
• MDR Text Key: 310059961
• Report Number: 1416980-2023-00629
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

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
• Device Operator: Other
• Device Catalogue Number: E1302OD
• Device Lot Number: 22C01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/26/2023
• 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