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

Lot Number GD912112

Device Problem Defective Device (2588)

Patient Problems Sepsis (2067); Peritonitis (2252)

Event Date 01/30/2023

Event Type  Injury  

Event Description

Peritoneal dialysis patient used a product that was later reported by baxter as being potentially defective.The pd minicap disconnect cap with povidone-iodine used on (b)(6) 2023 was reduced in effectiveness and patient developed sepsis and peritonitis resulting in a one-week hospital stay, pd antibiotics for 21 days, and a delay in unos transplant listing due to antibiotics.

• Brand Name: MINICAP DISCONNECT CAP WITH POVIDONE-IODINE
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 16436549
• MDR Text Key: 310284712
• Report Number: MW5115141
• 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: Unknown
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Lot Number: GD912112
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN; CONCERTA; ERGOCACIFEROL; IMURAN; ISRADIPINE (AS NEEDED); KEPPRA; LABETALOL HYDROCHLORIDE; LISINOPRIL; OMEPRAZOLE; PREDNISONE; PROCARDIA XL/ PHOSLO; RETACRIT; ROCALTROL; SENOKOT-S; ZOFRAN (AS NEEDED); ZOLOFT
• Patient Outcome(s): Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White