MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-24 for TUBE SET, STD VOL, STER H93811 manufactured by Baxter Healthcare Corporation.
[184647166]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184647167]
It was reported that a sterile repeater pump tube set leaked. The event was described as? The white spike end was not connected to the tubing?. It was further reported; the bag is spiked and? Put on the compounder and then prime tubing and then within seconds of priming the tubing the spike becomes loose and the liquid spills all over our iv hood (because the spike separates from the tubing)?. It appears? There was no glue or seal that keeping it connected to the tubing?. This issue was identified during compounding. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[188470714]
Additional information was added: the lot was manufactured from june 10, 2019 - june 12, 2019. The device was received for evaluation. Unaided visual inspection was performed which revealed the tube set tubing was detached from the tube set spike. No functional testing was performed. The reported condition was verified. The exact cause of the condition could not be determined; however, the probable cause is due to inadequate or lack of adhesive being applied during the manufacturing process. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2020-01663 |
| MDR Report Key | 9871578 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | AVAILMED |
| Manufacturer Street | C. INDUSTRIAL LT. 001 MZ. 105 NO 20905 INT A, COL CD IND. |
| Manufacturer City | TIJUANA, BAJA CALIFORNIA 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUBE SET, STD VOL, STER |
| Generic Name | SET, I.V. FLUID TRANSFER |
| Product Code | LHI |
| Date Received | 2020-03-24 |
| Model Number | NA |
| Catalog Number | H93811 |
| Lot Number | 60188266 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |