MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINICAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Device Problems Failure to Disconnect (2541); Detachment of Device or Device Component (2907)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was a connection issue between the peritoneal dialysis (pd) transfer set and effluent sample bag which resulted in peritonitis.While attempting to remove an effluent sample bag from the affected transfer set, it was observed that the female connector was coming loose from the light blue mainbody of the transfer set.The nurse was taking an effluent sample from the patient and was removing sample bag which was on so tight upon twisting noticed the blue tip of the transfer set was un-threading rather than the sample bag port.It was not reported if the patient was hospitalized for peritonitis.The patient was treated with unspecified intraperitoneal antibiotics (dose and frequency not reported) for peritonitis.At the time of this report, the patient outcome and action taken with pd therapy were not reported.The transfer set was replaced.No additional information is available.

Manufacturer Narrative

Correction was made to 'h1: type of reportable event' to change to 'serious injury' (previously reported as malfunction).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was added to h3 and h6.The actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was noted that there was a separation between the female connector and main body on the transfer set.The reported condition was verified.The cause of the reported condition was a manufacturing related issue caused by inadequate solvent to the insert chip.However, in the photograph provided, there was not enough information to evaluate the reported condition of a connection issue to the female connector or the connection to the effluent bag.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17768749
• MDR Text Key: 323700523
• Report Number: 1416980-2023-04706
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 09/22/2023; 10/16/2023
• Supplement Dates FDA Received: 09/27/2023; 10/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EFFLUENT SAMPLE BAG
• Patient Outcome(s): Required Intervention