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

Catalog Number 2C1155KP

Device Problem Break (1069)

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

Event Date 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address:(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume multirate infusor broke at the fill port.This was discovered prior to patient 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 which observed that the housing was malformed which caused the white color coil cap to separate from the housing of the device.When the housing is malformed, particularly at the neck area of the housing, the coil cap no longer fits the housing and it would separate from the housing.The reported condition of broken at the fill port was not verified however, the condition of a malformed housing resulting in coil cap separation was verified.The cause of the condition was due to the device being exposed to extreme heat temperature during shipping.The label on the product carton indicates "recommended storage temperature: room temperature.Avoid extreme temperature.¿ a nonconformance has been opened to address this issue.Malformed/deformed housing would be apparent at the time of preparation and filling of the device and rendering the device unusable.As this is an obvious issue that would be noted during preparation, the device would be discarded and not sent to the patient for use.The reported issue would lead to delay in therapy as the customer has the option to replace with new supplies.As specialty therapy devices are not intended for critical/life sustaining medication, the expected harm for delay of therapy is negligible.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: INFUSOR
• 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: 16881304
• MDR Text Key: 314726312
• Report Number: 1416980-2023-02191
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081403
• UDI-Public: (01)00085412081403
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K011317
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C1155KP
• Device Lot Number: 22D032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• 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