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TELOTIA REVIEW capa_2026_0178 / class_ii_infusion_pump human review required
CAPA review / corrective-action record

The CAPA identifies the affected device model and lot range.

Claim graph / citation path
claim corpus verdict source
Verdict queue
The CAPA identifies the affected device model and lot range.claim-018 / CAPA §2.1 Supported
Corrective actions address every root cause named in the investigation.claim-027 / Investigation §4 Partial
The design change was validated under the current QMSR.claim-041 / No cited passage Unsupported
Evidence search / scoped to supplied corpus

Each claim is matched only against the 47 files you supplied, never the open web.

matching · claim-018: CAPA identifies the affected device model and lot range
Investigation report · root-cause analysis§2.1 · model + lot range match
openFDA · recall recordrecall notice · affected lots match
MAUDE adverse eventsprior 24 months · adverse events partial
Design history file · validationindexed · no direct hit silent
Validation reports · V&Vno validation record found no match

Search is scoped to what you trust and can cite. The open web is never queried.

Verdict queue / run summary

18 claims graded. Each links back to its source.

Supported
11
Partial
4
Unsupported
3
The CAPA identifies the affected device model and lot range.claim-018 / CAPA §2.1 Supported
Corrective actions address every root cause named in the investigation.claim-027 / Investigation §4 Partial
The design change was validated under the current QMSR.claim-041 / No cited passage Unsupported

“Unsupported” means the corpus is silent on the claim, not that the claim is wrong.

Proof package / draft bundle

CAPA-2026-0178 · infusion pump · evidence bundle

capa_2026_0178 · drafted 09:45:06
The CAPA identifies the affected device model and lot range.cited · CAPA §2.1 Supported
Corrective actions address every root cause named in the investigation.cited · Investigation §4 · reviewer note Partial
The design change was validated under the current QMSR.flagged · no cited passage in corpus Unsupported
Human review required before submission · proof bundle draft ready

This bundle supports proof preparation. It does not grant regulatory approval or replace qualified human review.

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