MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FOLFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C4711K

Device Problem Material Rupture (1546)

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address: blekedammsvägen 27 should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the bladder of a small volume folfusor ruptured when adding glucose.The issue occurred during preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured july 19, 2022 to july 21, 2022.H10: one actual device was received for evaluation.A visual inspection on the unit via the naked eye noted fluid inside the housing.Further examination on the sample revealed the cause of fluid inside the housing was due to missing upper film-wrap.No evidence of rupture was observed from the bladder.The bladder was found to be in normal condition.For the small volume folfusor product, there are two film-wraps on the bladder: the upper and the lower.This complaint sample was missing both the upper and lower film-wrap on the bladder.The reported condition of rupture was not verified, however, the device was noted to be misassembled at the bladder and the stress member.The cause of the condition was due to manufacturing assembly error.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: FOLFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16806922
• MDR Text Key: 313927165
• Report Number: 1416980-2023-01964
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412082172
• UDI-Public: (01)00085412082172
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

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: 2C4711K
• Device Lot Number: 22G028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 05/30/2023
• 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
• Treatment: NA.