PUCK 6666 994G067E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-07 for PUCK 6666 994G067E manufactured by Siemens Medical Systems.

Event Text Entries

[4592] Pt had mild chronic renal failure but was in need of arteriogram and balloon angioplasty. During the otherwise successful procedure, he received 100 cc x-ray dye without imaging, due to machine malfunction. This resulted in a rough doubling of total contrast from 150-250 cc. Contrast is a known renal toxin. Pt's renal failure worsened (creatinine increased from 3. 6 to 5. 5) over the next few days. Still do not know final outcome as yet. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-nov-93. Service provided by: factory trained/authorized/owned service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: invalid data. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device repaired and put back in service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7287
• MDR Report Key: 7287
• Date Received: 1993-12-07
• Date of Report: 1993-11-18
• Date of Event: 1993-11-12
• Date Facility Aware: 1993-11-12
• Report Date: 1993-11-18
• Date Reported to FDA: 1993-11-18
• Date Reported to Mfgr: 1993-11-12
• Date Added to Maude: 1994-01-25
• 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: PUCK
• Generic Name: FILM CHANGER
• Product Code: KPX
• Date Received: 1993-12-07
• Model Number: 6666 994G067E
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-DEC-80
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6968
• Manufacturer: SIEMENS MEDICAL SYSTEMS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-12-07