MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-08 for RATE FLOW REGULATOR EXTENSION SET V5922 manufactured by B. Braun Medical Inc..
[2567939]
As reported by the user facility: reports overinfusion occurred with several sets. Facility performed testing, set at 100mls/hr, actually infused at 150mls/hr.
Patient Sequence No: 1, Text Type: D, B5
[9533843]
The actual device in the reported incident will not be returned for eval. W/o actual samples a thorough investigation could not be performed and no specific conclusions could be drawn. There have been no other reports of this nature against the reported lot numbers. All available info has been forwarded to the actual device mfr, (b)(4), for further eval. Although (b)(4) was not able to conduct an investigation on the actual product identified in this event, they did identify that excessive (b)(4) in the o-ring of the rate flow set can impact flow rate accuracy. (b)(4) has reviewed their mfg processes and although they have not detected any issues that could have led to excessive (b)(4) in these units, they have initiated a corrective action file in order to address this potential root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2011-00181 |
| MDR Report Key | 2419356 |
| Report Source | 05 |
| Date Received | 2011-12-08 |
| Date of Report | 2011-12-07 |
| Date of Event | 2011-10-25 |
| Date Mfgr Received | 2011-11-08 |
| Date Added to Maude | 2012-02-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIMBERLY PARIS |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 181099 |
| Manufacturer Country | US |
| Manufacturer Postal | 181099 |
| Manufacturer Phone | 6102660500 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RATE FLOW REGULATOR EXTENSION SET |
| Generic Name | RATE FLOW, REGULATOR I.V. SET |
| Product Code | LDR |
| Date Received | 2011-12-08 |
| Model Number | NA |
| Catalog Number | V5922 |
| Lot Number | 110721L / 110718L |
| ID Number | NA |
| Device Expiration Date | 2014-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | ALLENTOWN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-08 |