CADD ADMINISTRATION SET WITH FLOW STOP
Report
- Report Number
- 3012307300-2022-27841
- Event Type
- Malfunction
- Date Received
- December 13, 2022
- Report Date
- April 21, 2023
- Manufacturer
- ST PAUL
- Product Code
- FPA
- UDI-DI
- 30610586029640
- PMA / PMN Number
- K040636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: DEVICE EVALUATION: THE SAMPLES WERE RETURNED FOR INVESTIGATION. THE RETURNED SAMPLES WERE RECEIVED IN USED CONDITIONS WITHOUT THEIR ORIGINAL PACKAGING, DECONTAMINATED AND INSIDE IN A PLASTIC BAG. THE COMPLAINT RETURNED UNIT WAS VISUALLY INSPECTED UNDER NORMAL CONDITIONS OF ILLUMINATION. NO DAMAGE, KINKS, CUT, OR DEFORMATIONS WERE OBSERVED IN THE UNIT RETURNED THAT COULD CAUSE THE FAILURE MODE REPORTED. THE SAMPLE WAS SET FOR ACCURACY TESTING; SAMPLES 1 AND 4 PASSED, SAMPLES 2 AND 3 FAILED. NO DISCREPANCIES WERE DETECTED ON THE SAMPLE THE TEST SUCCESSFULLY PASSED. THE SAMPLES WERE TESTED TO MEASURE THE HEIGHT OF THE PUMP TUBE ARCH AND DETERMINE IF THEY WERE UNDER OR OUT OF SPEC; THE SAMPLES FAILED THE ARCH HEIGHT TUBE MEASURE TEST. THE FAILURE MODE REPORTED WAS CONFIRMED. CAPA-000903 WAS OPENED TO INVESTIGATE THE UNDER-DELIVERY/ NON-DELIVERY ISSUE REPORTED. THE ROOT CAUSE INVESTIGATION IDENTIFIED FLOW STOP FEATURE DIFFERENCES BETWEEN ARM OCCLUSION MOLDED PARTS AS THE MAJOR CAUSE FACTOR. CORRECTIVE ACTIONS WERE TAKEN BASED ON CAPA ABOVE. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO THE SUPPLIER. A DHR (DEVICE HISTORY REVIEW) WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). .
OTHER, OTHER TEXT: B5: DESCRIBE EVENT OR PROBLEM: UPDATED WITH ADDITIONAL INFORMATION RECEIVED.H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES ARE NOT REQUIRED.H10: NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING TO DATE. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE., CORRECTED DATA: H3: CORRECTION: DEVICE EVALUATED BY MANUFACTURER: DEVICE NOT RETURNED TO MANUFACTURER
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER ON (B)(6)-2022 VIA EMAIL AND ATTACHED TO THE COMPLAINT OBJECT. THE PUMP LOGS ARE AVAILABLE FOR TEN SEPARATE FILES. THE PUMP WILL NOT BE RETURNING AS IT APPEARS TO BE A TUBING ISSUE ONLY. (B)(4) SETS OF LOT 4290730 ARE AVAILABLE FOR RETURN. THE REPORTED ISSUE OCCURRED WHILE IN USE WITH THE PATIENT.
IT WAS REPORTED THAT WHEN THE PATIENT WENT TO FILL THE MEDICATION BAG, THE MEDICATION BAG WAS FULL, HOWEVER, THE PUMP SAID THAT THE RESIDUAL VOLUME WAS LOW. THE PATIENT STATED THAT THE PUMP DID NOT BEEP AT ALL UNTIL IT HIT LOW RESIDUAL VOLUME, WHICH IS WHEN HE NOTICED THAT THE MEDICATION IN THE BAG WAS NEVER INFUSED. ACCORDING TO THE PATIENT THE VOLUME OF MEDICATION LEFT IN THE BAG WAS APPROXIMATELY 300 MILLILITERS WHICH IS THE SAME AS THE ORIGINAL AMOUNT THE BAG WAS FILLED WITH. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450305 | CADD ADMINISTRATION SET WITH FLOW STOP | SET, ADMINISTRATION, INTRAVASCULAR | FPA | ST PAUL | 21-7322-24 | 30610586029640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male |