PALL BDS OXYGEN ANALYZER PBI 210480

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-07 for PALL BDS OXYGEN ANALYZER PBI 210480 manufactured by Pbi-dansensor A/s.

Event Text Entries

[27990593] Pall medical corporation's device the pall bds oxygen analyzer tested an platelets, apheresis unit as a false negative for bacteria. The unit was tested and then split into two products. The two products were distributed and transfused to two different patients. Both patients had an increase in temperature and pulse. They also experienced chills. The units were suspected to be contaminated with bacteria.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5137387
• MDR Report Key: 5137387
• Date Received: 2004-09-07
• Date of Report: 2004-09-03
• Date of Event: 2004-08-27
• Date Facility Aware: 2004-08-27
• Report Date: 2004-09-03
• Date Reported to FDA: 2004-09-03
• Date Reported to Mfgr: 2004-09-03
• Date Added to Maude: 2015-10-08
• 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: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: PALL BDS OXYGEN ANALYZER
• Generic Name: OXYGEN ANALYZER
• Product Code: MZC
• Date Received: 2004-09-07
• Model Number: NA
• Catalog Number: PBI 210480
• Lot Number: NA
• ID Number: C, 1.00 VAL009
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PBI-DANSENSOR A/S
• Manufacturer Address: RINGSTED DA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-09-07