MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXER MINICAP DISCONNECT CAP WITH POVIDONE-IODINE; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number 5C4466P

Device Problems Nonstandard Device (1420); Insufficient Flow or Under Infusion (2182); Protective Measures Problem (3015)

Patient Problems Septic Shock (2068); Peritonitis (2252)

Event Date 01/31/2023

Event Type  Death  

Event Description

My husband was using baxter minicap disconnect cap with povidone-iodine as part of his peritoneal at-home dialysis program.We noticed that one cap that we used did not have the expected amount of iodine oozing out of it during the connection process, but did not think too much of it.On (b)(6) 2023, my husband became ill and was taken to (b)(6) hospital in (b)(6) and died approximately 36 hours later.The cause of death listed on his death certificate was septic shock and peritonitis.On (b)(6) 2023, i received the first urgent medial device recall from baxter, detailing the issue with the product and providing the lot numbers for the affected products - which we had received, according to the packing slip we had received with the product.I have requested the medical records from (b)(6) hospital but have not received them yet.

• Brand Name: BAXER MINICAP DISCONNECT CAP WITH POVIDONE-IODINE
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 16529134
• MDR Text Key: 311160153
• Report Number: MW5115648
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 5C4466P
• Device Lot Number: GD912099
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 68 KG