FG6301 DUAL CHNL VOL INFUSIONPUMP,2M8064 RECONDND
Report
- Report Number
- 6000001-2011-00005
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- December 7, 2010
- Report Date
- December 9, 2010
- Manufacturer
- BAXTER HEALTHCARE - BUFFALO GROVE
- Product Code
- FRN
- PMA / PMN Number
- K915523
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NURSE
Narratives
(B)(4).
(B)(4). THE DEVICE PRINTED CIRCUIT BOARD (PCB) AND PUMP HEAD WERE RECEIVED BY THE BAXTER (B)(4) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. THE AIR SENSOR CALIBRATION TEST WAS PERFORMED AND VALUES FOUND WITHIN SPECIFICATION. THE PUMP1 WAS TESTED FOR ACCURACY PER PROCEDURE AND FOUND TO BE WITHIN SPECIFICATION (SPECIFICATION: RATE OF 60ML PER HOUR AND ABOVE: PLUS OR MINUS 7%, AND WITH RATE OF 1 TO 59.9ML PER HOUR: PLUS OR MINUS 10%). A SELF TEST , SLIDE CLAMP MECHANICAL, FSR CHECK, PANEL LOCK TEST, FREE FLOW PREVENTION TEST AND ONE HOUR ACCURACY TEST WERE PERFORMED. THE PUMP PASSED ALL TEST. THE PUMP WAS TESTED AT RATE OF 125MLPER HOUR FOR 1HOUR, PUMP DELIVERED PLUS 0.77%. THE PUMP WAS TESTED AT DIFFERENT RATES AND FOUND TO BE WITHIN SPECIFICATION. THE PUMP WAS TESTED THREE TIMES AT 200MLPER HOUR VOLUME TO BE INFUSED (VTBI) 35ML, PUMP DELIVERED PLUS 0.57%, MINUS 0.34% AND MINUS 0.60%. THE PUMP WAS TESTED AT 100MLPER HOUR FOR 1HR, PUMP DELIVERED PLUS 1.83%. THE PUMP WAS TESTED AT RATE OF 50MLPER PER HOUR FOR 1HOUR AND DELIVERED MINUS 2.96%. INSPECTION OF THE PUMP HEAD PUMP DOOR, AIR SENSOR, OCCLUSION SENSOR, BACKING PLATE, FINGERS AND HANDLE WAS PERFORMED AND NO PROBLEM FOUND. THE REPORTED CONDITION WAS NOT CONFIRMED OR DUPLICATED. THE ASSIGNABLE CAUSE IS UNDETERMINED. THE SOFTWARE VERSION FOR THIS PUMP IS NOT APPLICABLE. BAXTER PERFORMED A TREND REVIEW GLOBALLY FROM (B)(6) 2010 TO (B)(6) 2011 AND SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.
(B)(4). IT IS UNKNOWN IF THE DEVICE IS AVAILABLE TO BE RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. SHOULD THE DEVICE BE RETURNED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED.
(B)(4). THE DEVICE PRINTED CIRCUIT BOARD (PCB) AND PUMP HEAD WERE RECEIVED BY THE BAXTER (B)(4) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. THE AIR SENSOR CALIBRATION TEST WAS PERFORMED AND VALUES FOUND WITHIN SPECIFICATION. THE PUMP1 WAS TESTED FOR ACCURACY PER PROCEDURE AND FOUND TO BE WITHIN SPECIFICATION (SPECIFICATION: RATE OF 60ML PER HOUR AND ABOVE: PLUS OR MINUS 7%, AND WITH RATE OF 1 TO 59.9ML PER HOUR: PLUS OR MINUS 10%). A SELF TEST , SLIDE CLAMP MECHANICAL, FSR CHECK, PANEL LOCK TEST, FREE FLOW PREVENTION TEST AND ONE HOUR ACCURACY TEST WERE PERFORMED. THE PUMP PASSED ALL TEST. THE PUMP WAS TESTED AT RATE OF 125MLPER HOUR FOR 1HOUR, PUMP DELIVERED PLUS 0.77%. THE PUMP WAS TESTED AT DIFFERENT RATES AND FOUND TO BE WITHIN SPECIFICATION. THE PUMP WAS TESTED THREE TIMES AT 200MLPER HOUR VOLUME TO BE INFUSED (VTBI) 35ML, PUMP DELIVERED PLUS 0.57%, MINUS 0.34% AND MINUS 0.60%. THE PUMP WAS TESTED AT 100MLPER HOUR FOR 1HR, PUMP DELIVERED PLUS 1.83%. THE PUMP WAS TESTED AT RATE OF 50MLPER PER HOUR FOR 1HOUR AND DELIVERED MINUS 2.96%. INSPECTION OF THE PUMP HEAD PUMP DOOR, AIR SENSOR, OCCLUSION SENSOR, BACKING PLATE, FINGERS AND HANDLE WAS PERFORMED AND NO PROBLEM FOUND. THE REPORTED CONDITION WAS NOT CONFIRMED OR DUPLICATED. THE ASSIGNABLE CAUSE IS UNDETERMINED. THE SOFTWARE VERSION FOR THIS PUMP IS NOT APPLICABLE. BAXTER PERFORMED A TREND REVIEW GLOBALLY FROM (B)(6) 2010 TO (B)(6) 2011 AND SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.
(B)(4). THE DEVICE PRINTED CIRCUIT BOARD (PCB) AND PUMP HEAD WERE RECEIVED BY THE BAXTER (B)(4) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. THE AIR SENSOR CALIBRATION TEST WAS PERFORMED AND VALUES FOUND WITHIN SPECIFICATION. THE PUMP1 WAS TESTED FOR ACCURACY PER PROCEDURE AND FOUND TO BE WITHIN SPECIFICATION (SPECIFICATION: RATE OF 60ML PER HOUR AND ABOVE: PLUS OR MINUS 7%, AND WITH RATE OF 1 TO 59.9ML PER HOUR: PLUS OR MINUS 10%). A SELF TEST , SLIDE CLAMP MECHANICAL, FSR CHECK, PANEL LOCK TEST, FREE FLOW PREVENTION TEST AND ONE HOUR ACCURACY TEST WERE PERFORMED. THE PUMP PASSED ALL TEST. THE PUMP WAS TESTED AT RATE OF 125MLPER HOUR FOR 1HOUR, PUMP DELIVERED PLUS 0.77%. THE PUMP WAS TESTED AT DIFFERENT RATES AND FOUND TO BE WITHIN SPECIFICATION. THE PUMP WAS TESTED THREE TIMES AT 200MLPER HOUR VOLUME TO BE INFUSED (VTBI) 35ML, PUMP DELIVERED PLUS 0.57%, MINUS 0.34% AND MINUS 0.60%. THE PUMP WAS TESTED AT 100MLPER HOUR FOR 1HR, PUMP DELIVERED PLUS 1.83%. THE PUMP WAS TESTED AT RATE OF 50MLPER PER HOUR FOR 1HOUR AND DELIVERED MINUS 2.96%. INSPECTION OF THE PUMP HEAD PUMP DOOR, AIR SENSOR, OCCLUSION SENSOR, BACKING PLATE, FINGERS AND HANDLE WAS PERFORMED AND NO PROBLEM FOUND. THE REPORTED CONDITION WAS NOT CONFIRMED OR DUPLICATED. THE ASSIGNABLE CAUSE IS UNDETERMINED. THE SOFTWARE VERSION FOR THIS PUMP IS NOT APPLICABLE. BAXTER PERFORMED A TREND REVIEW GLOBALLY FROM (B)(6) 2010 TO (B)(6) 2011 AND SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.
THIS WAS A MALE CHILD HOSPITALIZED WITH ADMITTING DIAGNOSIS OF SHORT INTESTINE SYNDROME AND SEPSIS DUE TO CANDIDA AND GRAM NEGATIVE BACTERIA. THE PATIENT WAS INFUSING DEXTROSE 10% AT 2CC/HOUR WITH PARENTERAL NUTRITION AT 12CC/HOUR. THE PATIENT REPORTEDLY ALSO EXPERIENCED CHRONIC LOW NUTRITION. UNKNOWN ANTIBIOTICS WERE ADMINISTERED DUE TO THE INFECTIONS. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR 1 NIGHT TO MONITOR THE HYPERGLYCEMIA. PARENTERAL NUTRITION WAS CONTINUED WITHOUT FURTHER ISSUES. THE PATIENT'S CONDITION DECLINED DUE TO SEPSIS AND OTHER UNKNOWN CONDITIONS UNRELATED TO THE REPORTED EVENT. THE PATIENT EXPIRED ON (B)(6) 2011. THE LISTED CAUSE OF DEATH WAS: SEPSIS DUE TO MULTI-RESISTANT CANDIDA AND GRAM NEGATIVE BACTERIA. IT IS UNKNOWN IF CARDIOPULMONARY RESUSCITATION WAS INITIATED. THERE WAS NO ALLEGATION RELATED TO THE UNKNOWN INFUSION SET. THE PUMP IS CURRENTLY QUARANTINED. THERE IS NO ALLEGATION THAT THE PUMP MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.
ON (B)(6) 2010 A (B)(4) FACILITY REPORTED A FLO GARD PUMP WHICH INFUSED UNKNOWN MEDICATION PROGRAMMED TO INFUSE IN 24 HOURS WHICH OVERINFUSED IN 2 HOURS INTO A (B)(6) OLD BOY IN THE INTENSIVE CARE UNIT (ICU) FOR AN UNKNOWN DIAGNOSIS. THE CHILD WAS REPORTEDLY IN STABLE CONDITION. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED. THE STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FG6301 DUAL CHNL VOL INFUSIONPUMP,2M8064 RECONDND | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - BUFFALO GROVE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Death| H| R | DEXTROSE 10%| PARENTERAL NUTRITION |