UV-FLASH TM GERMICIDAL EXCHANGE DEVICE UNKNOWN 5C4336

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-12 for UV-FLASH TM GERMICIDAL EXCHANGE DEVICE UNKNOWN 5C4336 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[2239] Peritoneal dialysis patient performing routine exchange at home and had difficulty with exchange device mis-spiking new bag of dialysate. He brought device and transfer set in to dialysis unit to be examined. Outlet ports ports of several bags he brought in had indeed been punctured incorrectly. Staff attempts to duplicate this problem were unsuccessful x 4. Patients technique reviewed and suggestions made to prevent future problems. Transfer set was changed at this time to prevent possible contamination. Similar incident occurred 9/22/92. At this time, patient again brought in several bags with incorrectly punctured outlet ports. Again, staff were unble to duplicate the problem and made suggestions to patient regarding technique. Transfer set was changed to prevent infection. Patient presented with peritonitis on 9/26/92. Was admitted to hospital and treated with intraperitoneal antibiotics. Peritonitis relapsed on 10/5/92 and was discovered to be fungal in nature, requiring surgical removal of the peritoneal catheter and switch to in-center hemodialysis after insertion of a temporary vascular access (subclavian catheter). Additional devices involved included the uv-flash transfer set, the bag of new dialysate, the outlet port clamps used on the bag of dialysatedevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: mechanical tests performed, performance tests performed. Results of evaluation: failure to follow instructions. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3834
• MDR Report Key: 3834
• Date Received: 1993-02-12
• Date of Event: 1992-09-07
• Date Facility Aware: 1992-09-07
• Date Added to Maude: 1993-05-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UV-FLASH TM GERMICIDAL EXCHANGE DEVICE
• Generic Name: PERITONEAL DIALYSIS ASSIST DEVICE
• Product Code: FKO
• Date Received: 1993-02-12
• Model Number: UNKNOWN
• Catalog Number: 5C4336
• Lot Number: UNKNOWN
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3576
• Manufacturer: BAXTER HEALTHCARE CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-02-12