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

Catalog Number D2C4711K

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

It was reported that the event occurred on an unknown day in (b)(6) of 2020.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume folfusor ¿fell apart¿ and was leaking from an unspecified location.This event occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H4: the device was manufactured from april 27, 2020 - april 28, 2020.H10: the actual device was received for evaluation.A visual inspection was performed and found pink coil cap had separated from the housing.A functional leak test was performed on the unit by filling the bladder with green color water to the nominal volume.During and after fill, no evidence of leak was observed the cause of separated coil cap was due to malformed housing.The reported condition could not be verified; however, the most probable cause was due to shipping.Potential malformation of the housing can occur if the product is exposed to extreme heat temperature during shipping.The label on the product carton box has a recommended storage temperature to be "room temperature"; avoid extreme temperature.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.

Manufacturer Narrative

B5: upon updated information, the quantity of devices is unspecified.Update "a small volume folfusor" to "an unspecified quantity of small volume folfusors".Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10623136
• MDR Text Key: 209769875
• Report Number: 1416980-2020-06161
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412474311
• UDI-Public: (01)00085412474311
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2020

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
• Device Operator: Other
• Device Catalogue Number: D2C4711K
• Device Lot Number: 20D060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/20/2020; 11/05/2020
• Supplement Dates FDA Received: 11/04/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1