ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-27351
- Event Type
- Malfunction
- Date Received
- May 31, 2024
- Date of Event
- May 8, 2024
- Report Date
- September 6, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403811012
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2719-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.
OMIT : B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE. ADDITIONAL INFORMATION : DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER?, IMDRF ANNEX A, G, B, C, D CODES, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION # AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT.
IT WAS REPORTED AN UNDER INFUSION EVENT INVOLVING PRECEDEX. PER REPORT, AT 2100, THE CLINICIAN ASSESSED THE INFANT WHO WAS FOUND TO BE TACHYPNEIC, HAD INCREASED WORK OF BREATHING, HYPOTONIC, MINIMAL RESPONSE TO STIMULI, AND TEMPERATURE WAS 100.9 F. THE NEONATAL NURSE PRACTITIONER (NNP) WAS NOTIFIED AND CAME TO BEDSIDE. TEMPERATURE CHECKS WERE TAKEN EVERY 30 MINUTES X 4. AT 0050, THE TEMPERATURE WAS 100.2 F AND THE INFANT REMAINED TACHYPNEIC AND HAD INCREASED WORK OF BREATHING. THE NNP WAS AGAIN NOTIFIED AND CAME TO BEDSIDE. THE INFANT WAS PLACED ON OXYGEN, AND BLOOD CULTURE, COMPLETE BLOOD COUNT, CHEMISTRY, CAPILLARY BLOOD GLUCOSE, AND RENAL FUNCTION PANEL WERE OBTAINED. NO NEW ORDERS AT THIS TIME. AT 0430, THE TEMPERATURE WAS 99.6 F. WHEN "CLEARING IV PUMP AT 0600", THE RN NOTICED THE PUMP ONLY INFUSED 2.96ML OF PRECEDEX THIS SHIFT (12-HOUR SHIFT), WHEN 5.4ML SHOULD HAVE BEEN DELIVERED. PRECEDEX WAS INTENDED TO INFUSE AT 0.45ML/HR. THE RN FLUSHED THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LUMEN AND IT WAS REPORTEDLY "DIFFICULT TO FLUSH" INITIALLY. FLUIDS RESTARTED AND NNP AND DAY SHIFT RN WERE MADE AWARE. PE REPORT, THE SHORTLY FOLLOWING THIS EVENT, A PLEURAL EFFUSION WAS FOUND ON THE BABY'S CHEST XRAY. ACCORDING TO THE CLINICIAN, "A PLEURAL EFFUSION COULD DEFINITELY CAUSE INCREASED WORK OF BREATHING AND POSSIBLE INCREASED TEMPERATURE IF AFFECTED. THERE WAS NO HARM. IT WAS REPORTED THAT THE BEDSIDE NURSE ON 08 MAY 2024 CHANGED THE PUMP WHEN THE ISSUE WAS DISCOVERED. THE CLINICIAN USED THE TUBING UNTIL IT WAS DUE TO BE CHANGED. "NO THOUGHTS THAT THERE WAS A PROBLEM WITH THE TUBING." THE VOLUME ON 08 MAY 2024 AT 6PM WAS "CORRECT". THE CORRECT VOLUME OF MEDICATION WAS INFUSED ON 08 MAY 2024 BETWEEN 7A AND 7P.
IT WAS REPORTED AN UNDER INFUSION EVENT INVOLVING PRECEDEX. PER REPORT, AT 2100, THE CLINICIAN ASSESSED THE INFANT WHO WAS FOUND TO BE TACHYPNEIC, HAD INCREASED WORK OF BREATHING, HYPOTONIC, MINIMAL RESPONSE TO STIMULI, AND TEMPERATURE WAS 100.9 F. THE NEONATAL NURSE PRACTITIONER (NNP) WAS NOTIFIED AND CAME TO BEDSIDE. TEMPERATURE CHECKS WERE TAKEN EVERY 30 MINUTES X 4. AT 0050, THE TEMPERATURE WAS 100.2 F AND THE INFANT REMAINED TACHYPNEIC AND HAD INCREASED WORK OF BREATHING. THE NNP WAS AGAIN NOTIFIED AND CAME TO BEDSIDE. THE INFANT WAS PLACED ON OXYGEN, AND BLOOD CULTURE, COMPLETE BLOOD COUNT, CHEMISTRY, CAPILLARY BLOOD GLUCOSE, AND RENAL FUNCTION PANEL WERE OBTAINED. NO NEW ORDERS AT THIS TIME. AT 0430, THE TEMPERATURE WAS 99.6 F. WHEN "CLEARING IV PUMP AT 0600", THE RN NOTICED THE PUMP ONLY INFUSED 2.96ML OF PRECEDEX THIS SHIFT (12-HOUR SHIFT), WHEN 5.4ML SHOULD HAVE BEEN DELIVERED. PRECEDEX WAS INTENDED TO INFUSE AT 0.45ML/HR. THE RN FLUSHED THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LUMEN AND IT WAS REPORTEDLY "DIFFICULT TO FLUSH" INITIALLY. FLUIDS RESTARTED AND NNP AND DAY SHIFT RN WERE MADE AWARE. PE REPORT, THE SHORTLY FOLLOWING THIS EVENT, A PLEURAL EFFUSION WAS FOUND ON THE BABY'S CHEST XRAY. ACCORDING TO THE CLINICIAN, "A PLEURAL EFFUSION COULD DEFINITELY CAUSE INCREASED WORK OF BREATHING AND POSSIBLE INCREASED TEMPERATURE IF AFFECTED. THERE WAS NO HARM. IT WAS REPORTED THAT THE BEDSIDE NURSE ON (B)(6) 2024 CHANGED THE PUMP WHEN THE ISSUE WAS DISCOVERED. THE CLINICIAN USED THE TUBING UNTIL IT WAS DUE TO BE CHANGED. "NO THOUGHTS THAT THERE WAS A PROBLEM WITH THE TUBING." THE VOLUME ON (B)(6) 2024 AT 6PM WAS "CORRECT". THE CORRECT VOLUME OF MEDICATION WAS INFUSED ON (B)(6) 2024 BETWEEN 7A AND 7P.
IT WAS REPORTED AN UNDER INFUSION EVENT INVOLVING PRECEDEX. PER REPORT, AT 2100, THE CLINICIAN ASSESSED THE INFANT WHO WAS FOUND TO BE TACHYPNEIC, HAD INCREASED WORK OF BREATHING, HYPOTONIC, MINIMAL RESPONSE TO STIMULI, AND TEMPERATURE WAS 100.9 F. THE NEONATAL NURSE PRACTITIONER (NNP) WAS NOTIFIED AND CAME TO BEDSIDE. TEMPERATURE CHECKS WERE TAKEN EVERY 30 MINUTES X 4. AT 0050, THE TEMPERATURE WAS 100.2 F AND THE INFANT REMAINED TACHYPNEIC AND HAD INCREASED WORK OF BREATHING. THE NNP WAS AGAIN NOTIFIED AND CAME TO BEDSIDE. THE INFANT WAS PLACED ON OXYGEN, AND BLOOD CULTURE, COMPLETE BLOOD COUNT, CHEMISTRY, CAPILLARY BLOOD GLUCOSE, AND RENAL FUNCTION PANEL WERE OBTAINED. NO NEW ORDERS AT THIS TIME. AT 0430, THE TEMPERATURE WAS 99.6 F. WHEN "CLEARING IV PUMP AT 0600", THE RN NOTICED THE PUMP ONLY INFUSED 2.96ML OF PRECEDEX THIS SHIFT (12-HOUR SHIFT), WHEN 5.4ML SHOULD HAVE BEEN DELIVERED. PRECEDEX WAS INTENDED TO INFUSE AT 0.45ML/HR. THE RN FLUSHED THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LUMEN AND IT WAS REPORTEDLY "DIFFICULT TO FLUSH" INITIALLY. FLUIDS RESTARTED AND NNP AND DAY SHIFT RN WERE MADE AWARE. PE REPORT, THE SHORTLY FOLLOWING THIS EVENT, A PLEURAL EFFUSION WAS FOUND ON THE BABY'S CHEST XRAY. ACCORDING TO THE CLINICIAN, "A PLEURAL EFFUSION COULD DEFINITELY CAUSE INCREASED WORK OF BREATHING AND POSSIBLE INCREASED TEMPERATURE IF AFFECTED. THERE WAS NO HARM. IT WAS REPORTED THAT THE BEDSIDE NURSE ON (B)(6) 2024 CHANGED THE PUMP WHEN THE ISSUE WAS DISCOVERED. THE CLINICIAN USED THE TUBING UNTIL IT WAS DUE TO BE CHANGED. "NO THOUGHTS THAT THERE WAS A PROBLEM WITH THE TUBING." THE VOLUME ON (B)(6) 2024 AT 6PM WAS "CORRECT". THE CORRECT VOLUME OF MEDICATION WAS INFUSED ON (B)(6) 2024 BETWEEN 7A AND 7P.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308051 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403811012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | 8015.| 8100. |